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

16. juli 2026 opdateret af: KTH Biopharma
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Vietnam
    • None (International)
      • Hanoi, None (International), Vietnam, 121000
        • Rekruttering
        • National Dermatology Hospital, Hanoi, Vietnam.
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Combination of CO2 laser and placebo gel
Placebo gel contains saline gel
Andet: Placebo gel
Placebo gel contains saline
Eksperimentel: Combination of CO2 laser and Geniwa gel
Geniwa gel contains 5% alpha lactalbumin-oleic acid complexes
Medicin: Geniwa gel
Geniwa gel contains alpha lactalbumin-oleic acid 5%

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The efficacy
Tidsramme: 1-12 weeks of treatment
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
Tidsramme: 1-12 weeks of treatment
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Partial elimination
Tidsramme: 1-12 weeks of treatment
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
Tidsramme: 1 week-6 months
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
Tidsramme: 4-6 months after the last treatment
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
Tidsramme: 4-6 months after the last treatment
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

KTH Biopharma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juli 2026

Primær færdiggørelse (Anslået)

15. august 2027

Studieafslutning (Anslået)

15. september 2027

Datoer for studieregistrering

Først indsendt

30. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NHDV22.26

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Start date: 15/08-2027. No end date

IPD-delingsadgangskriterier

Secondary Researchers and Qualified Requestors.

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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