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Not Yet Recruiting
NCT07698886
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
Conditions: HPV (Human Papillomavirus)-Associated, Genital Warts
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 70
Sponsor: KTH Biopharma
Location: National Dermatology Hospital, Hanoi, Vietnam. Hanoi None (International)
Summary
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
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.
Source: ClinicalTrials.gov (NCT07698886). StuddyBuddy aggregates publicly available trial information.