A Phase 2 interventional study of Geniwa gel and Placebo gel in HPV (Human Papillomavirus)-Associated and Genital Warts, sponsored by KTH Biopharma. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by KTH Biopharma · Phase 2, Interventional, and Treatment
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. 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 lesion by investigator. The lesion was covered with a hydrocolloid dressing fastened with Micropore tape for 6 hours-10 hours (during the night). 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 wart lesions were inspected, measured, and photographed at enrollment, at week 2- 12 during the treatment period, and three to six months after the completion of treatment. The width, length, and height of each lesion were measured with the use of a slide caliper, and the volume of each genital wart lesion was calculated.
If genital warts recur during the first six-week period, CO2 laser treatment will be applied, followed by the continued use of a placebo or Geniwa topical gel. The randomization code was broken after all patients had completed six weeks of the randomly assigned treatment. Geniwa gel is predicted to be 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.
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 any other treatment they had received for genital warts, and about any other illness or treatment in the intervening period.
For patients who experience bleeding or significant wound pain after CO2 laser treatment, Geniwa or placebo topical gel application may not be possible until 1-2 days later.
Additionally, patients who undergo CO2 laser treatment are prescribed oral cefotaxime (for 7 days) and topical Tyrosur gel (Tyrothricin) daily (1-3 days) in the morning to reduce infection and promote wound healing. Tyrosur gel is used at different times of the day than placebo/Geniwa gel.
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's planned enrollment of 70 is below the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →This is the only study on the registry with KTH Biopharma as lead sponsor.
Compared within Condylomata Acuminata, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Papillomavirus Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo gel contains saline gel
Other: Placebo gel
Geniwa gel contains 5% alpha lactalbumin-oleic acid complexes
Drug: Geniwa gel
Geniwa gel contains alpha lactalbumin-oleic acid 5%
Placebo gel contains saline
The efficacy
Number of patients with complete elimination of all genital warts lesions at 12-week treatment period. Patients who achieved complete elimination of genital warts during treatment were assessed for recurrence within 4-6 months after the last treatment. The lession area is measured in cm2 or mm2.
Time frame: 12 weeks of treatment
Partial elimination
Number of patients with partial elimination, defined by a reduction of \>50% in lesion area compared to pre-treatment lesions at week 0 or week 6 (if recurrence). Lession area is measured in cm2.
Time frame: 1-12 weeks of treatment
New lesions
Number of patients with new lesions: assessment and comparison of the number, morphology, location, size (in cm or mm), and area (in cm2 or mm2) of recurrent lesions at weeks 3, 6, 9, and 12 (visually and with topical acetic acid).
Time frame: 1 week-6 months
Recurrence rate
Number of patients with recurrence rate: The recurrence rate is defined as the percentage of patients who were completely cured during treatment and experienced recurrent genital warts during the follow-up period.
Time frame: 4-6 months after the last treatment
The Safety
Percentage of patients experiencing at least one adverse event, percentage of patients experiencing at least one serious adverse event, the number of adverse events in each group.
Time frame: 1-12 weeks of treatment
Wart lesions
Number of wart lesions/patient
Time frame: 1-12 weeks of treatment
Plan to share: Yes — 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.
Supporting information: Study protocol, Clinical study report
Time frame: Start date: 15/08-2027. No end date
Access criteria: Secondary Researchers and Qualified Requestors. Information regarding the IPD sharing plan will be provided once the clinical trial is complete.
Started Jul 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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