Health Trials

Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel

ConditionsHPV (Human Papillomavirus)-AssociatedGenital Warts
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKTH Biopharma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older.

Able to read and understand the Patient Information Sheet and the Informed Consent form.

Acceptance in the participation of the essay and signature of the Informed Consent form.

Diagnosis of genital and anal warts with clear clinical manifestations.

Disqualifiers

Concomitant sexually transmitted infections such as gonorrhea, syphilis, genital herpes, etc., that have not been cured.

Ulceration or suspected malignant transformation of the lesions.

Local infections.

Pregnant women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Geniwa gel

    Drug

    Geniwa gel contains alpha lactalbumin-oleic acid 5%

  • Placebo gel

    Other intervention

    Placebo gel contains saline

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Combination of CO2 laser and placebo gelPlacebo comparator 1 intervention
Group B: Combination of CO2 laser and Geniwa gelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The efficacy

Number of patients with complete elimination of all genital warts lesions during the 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
1-12 weeks of treatment
2

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

Secondary outcomes

1

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
2

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
3

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
4

HPV clearance criteria

Number of patients with HPV clearance criteria: comparison of the percentage of positive HPV PCR at week 36 (after the last treatment) in patients who were completely cured during treatment.

Time frame
4-6 months after the last treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KTH Biopharma

Lead sponsor

Source ClinicalTrials.gov
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