Phase II, a randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness and recurrence of genital warts by combination of CO2 laser and Geniwa gel compared to laser CO2 combined with gel placebo. The clinical trial is conducted at National Dermatology Hospital, Hanoi, Vietnam.

Phase II, randomized, controlled and double blind clinical trial to evaluate the effectiveness and recurrence of genital warts by CO2 laser combined with Geniwa gel treatment compared Sixty to eighty patients with a history of genital warts that were resistant to conventional treatments were enrolled in a randomized, double-blind, placebo-controlled study comparing a combination of CO2 laser and Geniwa gel and a combination of CO2 laser and placebo gel.

In the first phase of the study, 60-80 patients were randomly assigned to 2 groups. The first group received a combination of CO2 laser and Geniwa gel for 6 weeks. The second group received a combination of CO2 laser and placebo gel for 6 weeks.

On day 1, after CO2 laser treatment, Geniwa gel (5% alpha lactalbumin-oleic acid) or saline placebo gel was applied to each lession by investigator. The lession was coverd with a hydrocolloid dressing fastened with Micropore tape for 6 hours-10 hours. Thereafter, the patients followed the same procedure at home once a day and received a new coded bottle (Geniwa or placebo gel) weekly in the clinic. The genital warts lession were inspected, measured, and photographed at enrollment, at week 3, 6, 9 and 12 during treatment period, and three to six months after the completion of treatment. The width, length, and height of each lesion were measured, with use of a slide caliper, and the volume of each genital warts was calculated.

If genital warts recur during first six-week period, CO2 laser treatment will be applied at week 6.

The randomization code was broken after all patients had completed six weeks of the randomly assigned treatment.

Geniwa gel is predicted superior to placebo. For this reason, patients in both groups were offered six weeks of open-label treatment with Geniwa gel according to the protocol used in the first, randomized phase of the study.

The patients participating in the second phase did not know whether they had received Geniwa or placebo during the first treatment period. After the end of open-label treatment with Geniwa, the patients were allowed to use conventional treatment if they wished it.

A short-term follow-up investigation was performed approximately 4-6 months after the completion of the second (open-label) treatment period. The sites of treated lesions and possible new lesions were inspected, and the patients were interviewed about the length of time to the resolution of their lesions, about potential other treatment they had received for genital warts, and about any other illness or treatment in the intervening period.

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 3 laser 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.

Images data, including HPV lesions, HPV tests, pathology HE staining, etc., will be shared using a code but will contain identifying images or personal information of the patient.

Start date: 15/08-2027. No end date

Secondary Researchers and Qualified Requestors.

Information regarding the IPD sharing plan will be provided once the clinical trial is complete.

A randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness and recurrence of genital warts by combination of CO2 laser and Geniwa gel compared to laser CO2 combined with gel placebo.