Genital warts treatment with CO2 laser plus Geniwa gel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, randomized, double-blind study compares CO2 laser treatment combined with Geniwa gel to CO2 laser treatment with placebo gel in adults with recurrent genital warts. Sixty to eighty participants who have failed prior therapies are enrolled at the National Dermatology Hospital in Hanoi, Vietnam. After laser treatment, either Geniwa gel or placebo is applied to each lesion and kept in place for several hours, with daily at-home applications for six weeks and follow-up assessments through three to six months post-treatment. Primary outcomes include wart clearance and recurrence, with lesion dimensions measured over time. The study uses a double-blind design to minimize bias, and data are collected on lesion size, number, and recurrence to evaluate added benefit of the gel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older.
2. Able to read and understand the Patient Information Sheet and the Informed Consent form.
3. Acceptance in the participation of the essay and signature of the Informed Consent form.
4. Diagnosis of genital and anal warts with clear clinical manifestations.
5. Have undergone at least 2 laser or nitrogen treatments and have experienced recurrence in any location.
6. At least four or more lesions, or a lesion area of at least 0.5 cm2.

Exclusion Criteria:

1. Concomitant sexually transmitted infections such as gonorrhea, syphilis, genital herpes, etc., that have not been cured.
2. Ulceration or suspected malignant transformation of the lesions.
3. Local infections.
4. Pregnant women.
5. Allergies to any component of alpha-lactalbumin-oleic acid gel.

Where it's running

• National Dermatology Hospital, Hanoi, Vietnam.
  Hanoi, None (International), Vietnam Recruiting

Study contacts

• Study coordinator: Thanh Tam Tran, MD
• Email: Tranthanhtam.fmh@gmail.com
• Phone: +84383744842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.