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

NCT07698886 | Recruiting Phase 2 DMC

• 1 other identifier: NHDV22.26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HPV (Human Papillomavirus)-Associated; Genital Warts

Keywords

HPV; Genital warts

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Partial elimination

  1-12 weeks of treatment

• New lesions

  1 week-6 months

• Recurrence rate

  4-6 months after the last treatment

• HPV clearance criteria

  4-6 months after the last treatment

Study Arms (2)

Combination of CO2 laser and placebo gel

PLACEBO COMPARATOR

Placebo gel contains saline gel

Other: Placebo gel

Combination of CO2 laser and Geniwa gel

EXPERIMENTAL

Geniwa gel contains 5% alpha lactalbumin-oleic acid complexes

Drug: Geniwa gel

Interventions

Geniwa gel DRUG

Geniwa gel contains alpha lactalbumin-oleic acid 5%

Combination of CO2 laser and Geniwa gel

Placebo gel OTHER

Placebo gel contains saline

Combination of CO2 laser and placebo gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have undergone at least 3 laser treatments and have experienced recurrence in any location.
• At least four or more lesions, or a lesion area of at least 0.5 cm2.

You may not qualify if:

• 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.
• Allergies to any component of alpha-lactalbumin-oleic acid gel.

Sponsors & Collaborators

• KTH Biopharma: lead

Study Sites (1)

National Dermatology Hospital, Hanoi, Vietnam.

Hanoi, None (International), 121000, Vietnam

RECRUITING

Related Publications (1)

• 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.

  PMID: 15215482 RESULT

MeSH Terms

Conditions

Papillomavirus Infections; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Thanh Tam Tran, MD

CONTACT

+84383744842; Tranthanhtam.fmh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 13, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• 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.

Locations

VN (1)