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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Genital Warts; HPV (Human Papillomavirus)-Associated
• Intervention / Treatment: Other: Placebo gel; Drug: Geniwa gel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Thanh Tam Tran, MD; Phone Number: +84383744842; Email: Tranthanhtam.fmh@gmail.com

Study Locations

• Vietnam
  • None (International)
    • Hanoi, None (International), Vietnam, 121000
      • National Dermatology Hospital, Hanoi, Vietnam.
      • Contact: Huy Luong Vu, MD, PhD; Phone Number: +84918150368; Email: huyluong84@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Combination of CO2 laser and placebo gel; Placebo gel contains saline gel	Other: Placebo gel; Placebo gel contains saline
Experimental: Combination of CO2 laser and Geniwa gel; Geniwa gel contains 5% alpha lactalbumin-oleic acid complexes	Drug: Geniwa gel; Geniwa gel contains alpha lactalbumin-oleic acid 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-12 weeks of 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.	1-12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	4-6 months after the last treatment
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.	4-6 months after the last treatment

Collaborators and Investigators

• Sponsor: KTH Biopharma

Publications and helpful links

General Publications

• Gustafsson L, Leijonhufvud I, Aronsson A, Mossberg AK, Svanborg C. Treatment of skin papillomas with topical alpha-lactalbumin-oleic acid. N Engl J Med. 2004 Jun 24;350(26):2663-72. doi: 10.1056/NEJMoa032454.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HPV; Genital warts
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases; Skin Diseases, Infectious; Tumor Virus Infections; Skin Diseases, Viral; Warts; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Papillomavirus Infections; Condylomata Acuminata
• Other Study ID Numbers: NHDV22.26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Start date: 15/08-2027. No end date

IPD Sharing Access Criteria

General Public: Anyone can browse and download reference sequences, nomenclature alignments, and general documentation.

Specialist Groups & Nomenclature Committees: These collaborators actively curate data and submit updates directly to the database.

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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No