Genital wart

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Genital wart(s)
Classification and external resources
Severe case of genital warts around the anus
ICD-10
A63.0
ICD-9
078.11
DiseasesDB
29120
eMedicine
derm/454 med/1037
MeSH
C02.256.650.810.217
Genital warts (or Condylomata acuminata, venereal warts, anal warts and anogenital
warts) is a highly contagious sexually transmitted disease caused by some sub-types of
human papillomavirus (HPV). It is spread through direct skin-to-skin contact during oral,
genital, or anal sex with an infected partner. Warts are the most easily recognized symptom of
genital HPV infection, where types 6 and 11 are responsible for 90% of genital warts cases.[1]
Whilst of those infected with genital HPV it is estimated that only a "small percentage"[2]
(between 1%[3] and 5%[4]) develop genital warts, those infected can still transmit the virus.
Other types of HPV also cause cervical cancer and probably most anal cancers, however it is
important to underline that the types of HPV that cause the overwhelming majority of genital
warts are not the same as those that can potentially increase the risk of genital or anal cancer.
[5][6][7][8][9]
HPV prevalence at any one time has been observed in some studies at 27% over all
sexually active people, rising to 45% between the ages of 14 and 19.[1]

Contents

1 Signs and symptoms

2 Diagnosis

3 Prevention

4 Management

5 Epidemiology

6 References

7 External links

Signs and symptoms

Genital warts often occur in clusters and can be very tiny or can spread into large masses in
the genital or penis area. In other cases they look like small stalks. In women they occur on
the outside and inside of the vagina, on the opening (cervix) to the womb (uterus), or around
(or inside) the anus. They are approximately as prevalent in men but the symptoms may be
less obvious. When present, they usually are seen on the tip of the penis. They also may be
found on the shaft of the penis, on the scrotum, or around (or inside) the anus. Rarely, genital
warts also can develop in the mouth or throat of a person who has had oral sex with an
infected person.[10]
The viral particles are able to penetrate the skin and mucosal surfaces through microscopic
abrasions in the genital area, which occur during sexual activity. Once cells are invaded by
HPV, a latency (quiet) period of months to years (decades) may occur. HPV can last for
several years without a symptom.[11] Having sex with a partner whose HPV infection is latent
and demonstrates no outward symptoms still leaves one vulnerable to becoming infected. If
an individual has unprotected sex with an infected partner, there is a 70% chance that he or
she will also become infected. The immune system eventually clears the virus through
interleukins, which recruit interferons, which slow viral replication.[12]

Severe case of genital warts on a female

Severe case of genital warts on a male

Diagnosis

Micrograph of a genital wart with the characteristic changes (parakeratosis, koilocytes,

papillomatosis). H&E stain.
Genital warts, histopathologically, characteristically rise above the skin surface due to
enlargement of the dermal papillae, have parakeratosis and the characteristic nuclear changes
typical of HPV infections (nuclear enlargement with perinuclear clearing).

Prevention
See also: HPV vaccine
Gardasil (sold by Merck & Co.) is a vaccine that protects against human papillomavirus types
16, 18, 6, and 11. Types 6 and 11 cause genital warts, while 16 and 18 cause cervical cancer.
The vaccine is preventive, not therapeutic, and must be given before exposure to the virus
type to be effective, ideally before the beginning of sexual activity. The vaccine is widely
approved for use by young women, it is being tested for young men,[13][14] and has been
approved for males in some areas, such as the UK, the US and Canada.

Management
There is no cure for HPV, but there are methods to treat visible warts, which could reduce
infectivity, although there are no trials studying the effectiveness of removing visible warts in
reducing transmission.[15] Every year, Americans spend $200 million on the treatment of
genital warts.[16] Genital warts may disappear without treatment, but sometimes eventually
develop a fleshy, small raised growth. There is no way to predict whether they will grow or
disappear. Warts can sometimes be identified because they show up as white when acetic acid
is applied, but this method is not recommended on the vulva because microtrauma and
inflammation can also show up as acetowhite.[12] Magnifying glasses or colposcope may also
be used to aid in identifying small warts.[12]
Depending on the sizes and locations of warts (as well as other factors), a doctor will offer
one of several ways to treat them. Podofilox is the first-line treatment due to its low cost.[17]
Almost all treatments can potentially cause depigmentation or scarring.[15]

A 0.15% 0.5% podophyllotoxin (also called podofilox) solution in a gel or cream.

Marketed as Condylox (0.5%), Wartec (0.15%) and Warticon (0.15%),[18] it can be
applied by the patient to the affected area and is not washed off. It is the purified and
standardized active ingredient of the podophyllin (see below). Podofilox is safer and
more effective than podophyllin.[18] Skin erosion and pain are more commonly
reported than with imiquimod and sinecatechins.[19] Its use is cycled (2 times per day
for 3 days then 47 days off); one review states that it should only be used for four
cycles.[20]

Imiquimod (Aldara) is a topical immune response cream, applied to the affected area.
It causes less local irritation than podofilox but may cause fungal infections (11% in
package insert) and flu-like symptoms (less than 5% disclosed in package insert).[19]

Sinecatechins (marketed as Veregen and Polyphenon E) is an ointment of catechins

(55% epigallocatechin gallate[12]) extracted from green tea and other components.

Mode of action is undetermined.[21] It appears to have higher clearance rates than

podophyllotoxin and imiquimod and causes less local irritation, but clearance takes
longer than with imiquimod.[19]

Liquid nitrogen cryosurgery is safe for pregnancy. It kills warts 7179% of the time,
but recurrence is 38% to 73% 6 months after treatment.[12] Local infections have been
reported.[12]

Trichloroacetic acid (TCA) is less effective than cryosurgery,[20] and is not

recommended for use in the vagina, cervix, or urinary meatus.[12]

Surgical excision is best for large warts, and has a greater risk of scarring.[15]

Laser ablation does not seem to be any more effective than other physician-applied
methods,[3] but is often used as a last resort and is extremely expensive.[12]

A 20% podophyllin anti-mitotic solution, applied to the affected area and later washed
off. However, this crude herbal extract is not recommended for use on vagina, urethra,
perianal area, or cervix,[12] and must be applied by a physician.[18] Reported reactions
include nausea, vomiting, fever, confusion, coma, renal failure, ileus, and leukopenia;
death has been reported with extensive topical application, or application on mucous
membranes.[12]

Interferon can be used; it is effective, but it is also expensive and its effect is
inconsistent.[20]

Electrocauterization can be used; it is an older procedure but recovery time is

generally longer. In severe cases of genital warts, treatment may require general or
spinal anesthesia. This is a surgical procedure. More effective than cryosurgery and
recurrence is at a much lower rate.

Oral Isotretinoin is a therapy that has proven effective in experimental use, but is
rarely used due to potentially severe side effects. In a small-scale study, low dose oral
isotretinoin showed considerable efficacy and may represent an alternative systemic
form of therapy for Genital Warts. Yet, albeit this indicative evidence not many
studies have been conducted to further confirm the findings. In most countries this
therapy is currently unapproved and only used as an alternative therapy if other
therapies failed.[22]'[23]

Discontinued

A 5% 5-fluorouracil (5-FU) cream was used, but it is no longer considered an

acceptable treatment due to the side-effects.[12]

Podophyllin, podofilox and Isotretinoin should not be used during pregnancy, as they could
cause birth defects in the fetus.

Epidemiology

Genital HPV infections have an estimated prevalence in the US of 1020% and clinical
manifestations in 1% of the sexually active adult population.[20] US incidence of HPV
infection has increased between 1975 and 2006.[20] About 80% of those infected are between
the ages of 1733.[20] Although treatments can remove the warts, they do not remove the HPV,
so warts can recur after treatment (about 5073% of the time[24]). Warts can also
spontaneously regress (with or without treatment).[20] Traditional theories postulated that the
virus remained in the body for a lifetime. However, new studies using sensitive DNA
techniques have shown that through immunological response the virus can either be cleared
or suppressed to levels below what polymerase chain reaction (PCR) tests can measure. One
study testing genital skin for subclinical HPV using PCR found a prevalence of 10%.[20]

References
1.
2.

^ a b http://www.webmd.com/sexual-conditions/hpv-genital-warts/hpv-virusinformation-about-human-papillomavirus
^ http://www.aad.org/public/publications/pamphlets/viral_genital.html

3.

^ a b O'Mahony C (2005). "Genital warts: current and future management

options". Am J Clin Dermatol 6 (4): 239243. PMID 16060711.

4.

^ http://www.mckinley.illinois.edu/Handouts/genital_warts.html

5.

^ http://96.10.7.92/hpv_diagnosing.shtml

6.

^ http://dermatology.cdlib.org/126/original/HPV/payal.html

7.

^ http://www.cdc.gov/std/hpv/stdfact-hpv.htm

8.

^ http://www.cancerhelp.org.uk/type/cervical-cancer/about/cervical-cancerrisks-and-causes#hpv

9.

^
http://brown.edu/Student_Services/Health_Services/Health_Education/sexual_health/
sexually_transmitted_infections/hpv.php

10.

^ Genkins, Gill. "Genital warts". BBC. Retrieved 17 November 2011.

11.

^ "American Cancer Society: "Can Anal Cancer Be Prevented?"". Retrieved

2008-09-10.[dead link]

12.

^ a b c d e f g h i j k Mayeaux EJ, Dunton C (July 2008). "Modern management of

external genital warts". J Low Genit Tract Dis 12 (3): 185192.
doi:10.1097/LGT.0b013e31815dd4b4. PMID 18596459.

13.

^ Cortez, Michelle Fay and Pettypiece, Shannon. "Merck Cancer Shot Cuts
Genital Warts, Lesions in Men". Bloomberg News. (Bloomberg.com) 13 Nov 2008.

14.

^ HPV Vaccine Gardasil May Help Boys, Men by WebMD Health News, Nov
13, 2008

15.

^ a b c Kodner CM, Nasraty S (December 2004). "Management of genital

warts". Am Fam Physician 70 (12): 23352342. PMID 15617297.

16.

^ "STI Awareness: Genital Warts". Planned Parenthood Advocates of Arizona.

2012-04-18. Retrieved 2012-04-20.

17.

^ Fox PA, Tung MY (2005). "Human papillomavirus: burden of illness and

treatment cost considerations". Am J Clin Dermatol 6 (6): 365381. PMID 16343025.

18.

^ a b c von Krogh G, Longstaff E (December 2001). "Podophyllin office

therapy against condyloma should be abandoned". Sex Transm Infect 77 (6): 409412.
doi:10.1136/sti.77.6.409. PMC 1744412. PMID 11714936.

19.

^ a b c Meltzer SM, Monk BJ, Tewari KS (March 2009). "Green tea catechins
for treatment of external genital warts". Am. J. Obstet. Gynecol. 200 (3): 233.e17.
doi:10.1016/j.ajog.2008.07.064. PMID 19019336.

20.

^ a b c d e f g h Scheinfeld N, Lehman DS (2006). "An evidence-based review of

medical and surgical treatments of genital warts". Dermatol. Online J. 12 (3): 5.
PMID 16638419.

21.

^ "Veragen package insert" (PDF). Retrieved 2008-08-18.[dead link]

22.

^ S Georgala, A C Katoulis, C Georgala, E Bozi, A Mortakis (November

2004). "Oral isotretinoin in the treatment of recalcitrant condylomata acuminata of the
cervix: a randomised placebo controlled trial". Sex Transm Infect 80 (3): 216218.
doi:10.1136/sti.2003.006841.

23.

^ Virendra N. Sehgal MD, Govind Srivastava MD, Kabir Sardana MD (May

2006). "Isotretinoin unapproved indications/uses and dosage: a physician's
reference". International Journal of Dermatology 45 (6): 772777.
doi:10.1111/j.1365-4632.2006.02830.x.

24.

^ CDC. (2004). REPORT TO CONGRESS: Prevention of Genital Human

Papillomavirus Infection.

A.D.A.M. Medical Encyclopedia.

Genital warts
Condylomata acuminata; Penile warts; Human papilloma virus (HPV); Venereal
warts; Condyloma; HPV DNA test; Sexually transmitted disease (STD) - warts;
LSIL-HPV; Low-grade dysplasia-HPV; HSIL-HPV; High-grade dysplasia HPV; HPV

Last reviewed: November 7, 2011.

Genital warts are soft growths on the skin and mucus membranes of the genitals. They may
be found on the penis, vulva, urethra, vagina, cervix, and around and in the anus.
Genital warts are a sexually transmitted infection (STI).
Causes, incidence, and risk factors

The virus that causes genital warts is called human papilloma virus (HPV). More than 70
different types of HPV exist. Certain types of HPV can lead to precancerous changes in the
cervix, cervical cancer, or anal cancer. These are called high-risk types of HPV.
Not all types of HPV cause genital warts. Other types of HPV cause warts on other parts of
the skin, such as the hands. This article focuses on warts on the genitals.
HPV infection around the genitals is common. However, most people have no symptoms. In
women, HPV can spread to areas inside the walls of the vagina and cervix. They are not easy
to see without special procedures.
Important facts about HPV:

HPV infection spreads from one person to another through sexual contact involving
the anus, mouth, or vagina. You can spread the warts even if you do not see them.

You may not see warts for 6 weeks to 6 months after becoming infected. You may not
notice them for years.

Not everyone who has come into contact with the HPV virus and genital warts will
develop them.

You are more likely to get genital warts and spread them more quickly if you:

Have multiple sexual partners

Do not know if you had sex with had STIs

Are sexually active at an early age

Use tobacco and alcohol

Have a viral infection such as herpes and are stressed at the same time

Are pregnant

Have a weakened immune system due to an illness or medication

If a child has genital warts, you should suspect sexual abuse as a possible cause.

Symptoms

Genital warts may be so tiny, you might not see them.

The warts may look like:

Flesh-colored spots that are raised or flat

Growths that look like the top of a cauliflower

In females, genital warts may be found:

Inside the vagina or anus

Outside the vagina or anus, or on nearby skin

On the cervix inside the body

In males, genital warts may be found on the:

Penis

Scrotum

Groin area

Thighs

Inside or around the anus

Genital warts may also occur on the

Lips

Mouth

Tongue

Throat

Other symptoms are rare, but may include:

Increased dampness in the genital area near the warts

Increased vaginal discharge

Genital itching

Vaginal bleeding during or after sex

Signs and tests

The health care provider will perform a physical exam.

In women, this will include a pelvic examination. Magnification (colposcopy) is used to spot
warts that cannot be seen with the naked eye. Your doctor may place watered-down vinegar
(acetic acid) on the area. This helps better see any warts.
The virus that causes genital warts can cause abnormal results on a Pap smear. If you have
these types of changes, you will probably need more frequent Pap smears for a while.
An HPV DNA test can tell if you have a high-risk type of HPV known to cause cervical
cancer. This test may be done:

As a screening test for women over age 30

In women of any age who have a slightly abnormal Pap test result

Treatment

Genital warts must be treated by a doctor. Do NOT use over-the-counter medicines meant for
other kinds of warts.
Treatment may include:

A skin treatment done in the doctor's office

Prescription medicine that you apply at home several times per week

Prescription medicines include:

Imiquimod (Aldara)

Podophyllin and podofilox (Condylox)

Trichloroacetic acid (TCA)

The warts may be removed with surgery, including:

Cryosurgery

Electrocauterization

Laser therapy

Surgical excision (cutting them out)

If you have genital warts, all of your sexual partners must be examined by a health care
provider and treated if warts are found. Even if you do NOT have symptoms, you must be
treated to prevent complications and spreading the condition to others.
You will need to return to your health care provider after treatment to make sure all the warts
are gone.
Regular Pap smears are recommended if you are a woman who has had genital warts, or if
you parter had them. If you had warts on your cervix, you may need to have Pap smears
every 3 to 6 months after the first treatment.
Women with precancerous changes caused by HPV infection may need further treatment.
Young women and girls ages 9 - 26 should be vaccinated against HPV, even if they already
have genital warts, though the vaccine is somewhat less effective in preventing cervical
cancer if you have already had an infection with high risk HPV.
Expectations (prognosis)

Many sexually active young women become infected with HPV. In many cases, HPV goes
away on its own.
Most men who become infected with HPV never develop any symptoms or problems from
the infection. However, they can pass it on to current and sometimes future sexual partners.
Even after you have been treated for genital warts, you may still infect others.
Complications

Some types of HPV have been found to cause cancer of the cervix and vulva. They are the
main cause of cervical cancer.
The types of HPV that can cause genital warts are not the same as the types that can cause
penile or anal cancer.
The warts may become numerous and quite large, requiring more extensive treatment and
follow-up procedures.
Calling your health care provider

Call your doctor if:

A current or past sexual partner has genital warts

You have visible warts on your external genitals, itching, discharge, or abnormal
vaginal bleeding. Keep in mind that genital warts may not appear for months to years
after having sexual contact with an infected person.

You think a young child might have genital warts

Women should begin having Pap smears at age 21.

Prevention

Not having sexual contact is the only foolproof way to avoid genital warts and other STIs.
You can also decrease your chance of getting an STI by having a sexual relationship with
only one partner who you know is disease-free.
Male and female condoms cannot fully protect you, because the virus or warts can be on
nearby skin. Nonetheless, condoms reduce your risk and you should still use them at all
times. HPV can be passed from person to person even when there are no visible warts or
other symptoms. See: Safe sex
Two vaccines are available that protect against four of the HPV types that cause most cervical
cancers in women. The vaccine is given as a series of three shots. It is recommended for girls
and women ages 9 to 26.
See: HPV vaccine for more detailed information.
References
1. Diaz ML. Human papilloma virus: prevention and treatment.Obstet
Gynecol Clin North Am. 2008;35(2):199-217.
2. Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy
A, et al. Human papillomavirus DNA versus Papanicolaou screening tests
for cervical cancer. N Engl J Med. 2007;357:1579-1588.
3. Kahn JA. HPV vaccination for the prevention of cervical intraepithelial
neoplasia. N Engl J Med. 2009;361:271-278.

Review Date: 11/7/2011.

Reviewed by: David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.; Susan
Storck, MD, FACOG, Chief, Eastside Department of Obstetrics and Gynecology,
Group Health Cooperative of Puget Sound, Bellevue, Washington; Clinical Teaching
Faculty, Department of Obstetrics and Gynecology, University of Washington School
of Medicine.

A.D.A.M., Disclaimer

Copyright 2012, A.D.A.M., Inc.

Condylox Solution - Detailed Prescribing Information
>
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Manufacturer
Contents
Indications
Dosage
Overdosage
Contraindications

> Warnings
> Adverse Drug Reactions

> Description
> Mechanism of Action
> Presentation/Packing

Related monographs

See related Condylox Solution information

Manufacturer

Watson Pharmaceuticals Inc

Contents

Topical Solution (52544-046) podofilox 5 milligram in 1 milliliter

Indications

Condylox 0.5% Solution is indicated for the topical treatment of external

genital warts (Condyloma acuminatum). This product is not indicated in
the treatment of perianal or mucous membrane warts
(seePRECAUTIONS).
Diagnosis

Although genital warts have a characteristic appearance, histopathologic

confirmation should be obtained if there is any doubt of the diagnosis.
Differentiating warts from squamous cell carcinoma (so-called
"Bowenoid papulosis") is of particular concern. Squamous cell
carcinoma may also be associated with human papillomavirus but should
not be treated with Condylox 0.5% Solution.
Dosage

In order to ensure that the patient is fully aware of the correct method of
therapy and to identify which specific warts should be treated, the
technique for initial application of the medication should be
demonstrated by the prescriber.
Apply twice daily morning and evening (every 12 hours), for 3
consecutive days, then withhold use for 4 consecutive days. This one
week cycle of treatment may be repeated up to four times until there is
no visible wart tissue. If there is incomplete response after four treatment

weeks, alternative treatment should be considered. Safety and

effectiveness of more than four treatment weeks have not been
established.
Condylox 0.5% Solution is applied to the warts with a cotton-tipped
applicator supplied with the drug. The drug-dampened applicator should
be touched to the wart to be treated, applying the minimum amount of
solution necessary to cover the lesion. Treatment should be limited to
less than 10 cm2 of wart tissue and to no more than 0.5 mL of the
solution per day. There is no evidence to suggest that more frequent
application will increase efficacy, but additional applications would be
expected to increase the rate of local adverse reactions and systemic
absorption.
Care should be taken to allow the solution to dry before allowing the
return of opposing skin surfaces to their normal positions. After each
treatment, the used applicator should be carefully disposed of and the
patient should wash his or her hands.
Overdosage

Topically applied podofilox may be absorbed systemically

(seeCLINICAL PHARMACOLOGY section). Toxicity reported
following systemic administration of podofilox in investigational use for
cancer treatment included: nausea, vomiting, fever, diarrhea, bone
marrow depression, and oral ulcers. Following 5 to 10 daily intravenous
doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred
but was reversible. Other toxicities occurred at lower doses. Toxicity
reported following systemic administration of podophyllum resin
included: nausea, vomiting, fever, diarrhea, peripheral neuropathy,
altered mental status, lethargy, coma, tachypnea, respiratory failure,
leukocytosis, pancytosis, hematuria, renal failure, and seizures.
Treatment of topical overdosage should include washing the skin free of
any remaining drug and symptomatic and supportive therapy.

Contraindicatio Condylox 0.5% Solution is contraindicated for patients who develop

ns
hypersensitivity or intolerance to any component of the formulation.
Warnings

Correct diagnosis of the lesions to be treated is essential. See the

"Diagnosis" subsection of theINDICATIONS AND USAGE statement.
Condylox 0.5% Solution is intended for cutaneous use only. Avoid
contact with the eye. If eye contact occurs, patients should immediately
flush the eye with copious quantities of water and seek medical advice.

Special

General

Precautions

Data are not available on the safe and effective use of this product for
treatment of warts occurring in the perianal area or on mucous
membranes of the genital area (including the urethra, rectum and
vagina). The recommended method of application, frequency of
application, and duration of usage should not be exceeded (seeDOSAGE
AND ADMINISTRATION).
Information for Patients

The patient should be provided with a Patient Information leaflet when a

Condylox prescription is filled.
Carcinogenesis, Mutagenesis, Impairment of Fertility

Reports of lifetime carcinogenicity studies in mice are not available.

Published animal studies, in general, have not shown the drug substance,
podofilox, to be carcinogenic.1,2,3,4,5 There are published reports that,
in mouse studies, crude podophyllin resin (containing podofilox) applied
topically to the cervix produced changes resembling carcinoma in situ.6
These changes were reversible at five weeks after cessation of treatment.
In one reported experiment, epidermal carcinoma of the vagina and
cervix was found in 1 out of 18 mice after 120 applications of
podophyllin7 (the drug was applied twice weekly over a 15-month
period).
Podofilox was not mutagenic in the Ames plate reverse mutation assay at
concentrations up to 5 mg/plate, with and without metabolic activation.
No cell transformation related to potential oncogenicity was observed in
BALB/3T3 cells after exposure to podofilox at concentrations up to
0.008 g/mL without metabolic activation and 12 g/mL podofilox with
metabolic activation. Results from the mouse micronucleus in vivo assay
using podofilox 0.5% solution in concentrations up to 25 mg/kg, indicate
that podofilox should be considered a potential clastogen (a chemical
that induces disruption and breakage of chromosomes).
Daily topical application of Condylox 0.5% Solution at doses up to the
equivalent of 0.2 mg/kg (5 times the recommended maximum human
dose) to rats throughout gametogenesis, mating, gestation, parturition
and lactation for two generations demonstrated no impairment of
fertility.
Pregnancy

Category C: Podofilox was not teratogenic in the rabbit following topical

application of up to 0.21 mg/kg (5 times the maximum human dose)

once daily for 13 days. The scientific literature contains references that
podofilox is embryotoxic in rats when administered systemically in a
dose approximately 250 times the recommended maximum human
dose.8,9 Teratogenicity and embryotoxicity have not been studied with
intravaginal application. Many antimitotic drug products are known to be
embryotoxic. There are no adequate and well-controlled studies in
pregnant women. Podofilox should be used in pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Nursing Mothers

It is not known whether this drug is excreted in human milk. Because of

the potential for serious adverse reactions in nursing infants from
podofilox, a decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance of the drug to
the mother.
Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Drug
Reactions

In clinical trials, the following local adverse reactions were reported at

some point during treatment.
Adverse Experience

Males

Females

Burning

64%

78%

Pain

50%

72%

Inflammation

71%

63%

Erosion

67%

67%

Itching

50%

65%

Reports of burning and pain were more frequent and of greater severity
in women than in men.
Adverse effects reported in less than 5% of the patients included pain
with intercourse, insomnia, tingling, bleeding, tenderness, chafing,
malodor, dizziness, scarring, vesicle formation, crusting edema,
dryness/peeling, foreskin irretraction, hematuria, vomiting and
ulceration.
Description

Condylox is the brand name of podofilox, an antimitotic drug which can

be chemically synthesized or purified from the plant families Coniferae

and Berberidaceae (e.g. species of Juniperus and Podophyllum).
Condylox 0.5% Solution is formulated for topical administration. Each
milliliter of solution contains 5 mg of podofilox, in a vehicle containing
lactic acid and sodium lactate in alcohol 95%, USP.
Podofilox has a molecular weight of 414.4 daltons, and is soluble in
alcohol and sparingly soluble in water. Its chemical name is 5,8,8a,9Tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)furo[3',4':6,7]
naphtho[2,3,d]-1, 3-dioxol-6(5aH)-one. Podofilox has the following
structural formula:

Mechanism of
Action

CLINICAL PHARMACOLOGY
Mechanism of Action

Treatment of genital warts with podofilox results in necrosis of visible

wart tissue. The exact mechanism of action is unknown.
Pharmacokinetics

In systemic absorption studies in 52 patients, topical application of 0.05

mL of 0.5% podofilox solution to external genitalia did not result in
detectable serum levels. Applications of 0.1 to 1.5 mL resulted in peak
serum levels of 1 to 17 ng/mL one to two hours after application. The
elimination half-life ranged from 1.0 to 4.5 hours. The drug was not
found to accumulate after multiple treatments.
CLINICAL STUDIES

In clinical studies with Condylox Solution, the test product and its
vehicle were applied in a double-blind fashion to comparable patient
groups. Patients were treated for two to four weeks, and reevaluated at a
two-week follow-up examination. Although the number of patients and
warts evaluated at each time period varied, the results among

investigators were relatively consistent.

The following table represents the responses noted in terms of frequency
of response by lesions treated and the overall response by patients. Data
are presented for the 2-week follow-up only for those patients evaluated
at that time point.
Responses in Treated Patients
Initially

Recurred after

Cleared

Cleared*

Clearing*

at 2-Week Follow-up

*Cleared and clearing mean no visible wart tissue remained at the

treated sites
% Warts

79%

35%

60%

(n=524)

(412/524)

(146/412)

(269/449)

% Patients

50%

60%

25%

(n=70)

(35/70)

(21/35)

(14/57)

Presentation/Pa HOW SUPPLIED

cking

3.5 mL of Condylox 0.5% Solution is supplied as a clear liquid in amber

glass bottles with child-resistant screw caps. NDC 52544-046-13. Store
at controlled room temperature between 15 - 30C (59 - 86F). Avoid
excessive heat. Do not freeze.
Rx only
REFERENCES
1. Berenblum I. The effect of podophyllotoxin on the skin of the
mouse, with reference to carcinogenic, cocarcinogenic, and
anticarcinogenic action. J Cancer Inst 11:839-841, 1951.
2. Kaminetzky HA, Swerdlow M. Podophyllin and the mouse
cervix: assessment of carcinogenic potential. Am J Obst Gyn
95:486-490, 1965.
3. McGrew EA, Kaminetzky HA. The genesis of experimental
cervical epithelial dysplasia. Am J Clin Path 35:538-545, 1961.
4. Roe FJC, Salaman MH. Further studies on incomplete

carcinogenesis: triethylene melamine (T.E.M.) 1,2

benxanthracene and beta-propiolactone as initiators of skin tumor
formation in the mouse. Brit J Cancer, 9:177-203, 1955.
5. Taper HS. Induction of the deficient acid DNAase activity in
mouse interfollicular epidermis by croton oil as a possible tumor
promoting mechanism. Zeitschrift fur Krebsforschung and
Klinisch Onkologie (Cancer Research and Clinical Oncology,
Berlin). 90:197-210, 1977.
6. Kaminetzky HA, McGrew EA, Phillips RL. Experimental
cervical epithelial dysplasia. J Obst Gyn 14:1-10, 1959.
7. Kaminetzky HA, McGrew EA: Podophyllin and mouse cervix:
Effect of long term application. Arch Path 73:481-485, 1962.
8. Didcock K, Jackson D, Robson JM. The action of some
nucleotoxic substances on pregnancy. Brit J Pharmacol 11:437441, 1956.
9. Thiersch JB. Effect of podophyllin (P) and podophylotoxine (PT)
on the rat litter in utero. Soc Exptl Biol Med Proc. 113:124-127,
1963.
Mfd. for
Watson Pharmaceuticals, Inc.
Corona, CA 92880 USA
by DPT Labs. Ltd.,
San Antonio, TX 78215
128715-1107
S1107
Presentation/Packing
Form

Packing

Topical Solution

3.5 milliliter in 1 bottle, glass

Manufactur
Watson Pharmaceuticals Inc
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