HPV (Human Papillomavirus)-AssociatedPhase 2NCT07698886
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
A Phase 2 study testing Geniwa gel in people with HPV (Human Papillomavirus)-Associated and Genital Warts, run by KTH Biopharma at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV (Human Papillomavirus)-Associated, Genital Warts
- What is being tested?
- Geniwa gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteVietnam
- Study dates
- 16 Jul 2026to 15 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Have undergone at least 2 laser or nitrogen treatments and have experienced recurrence in any location.
- At least four or more lesions, or a lesion area of at least 0.5 cm2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
National Dermatology Hospital, Hanoi, Vietnam.
Hanoi, None (International), 121000
Huy Luong Vu, MD, PhD, +84918150368, huyluong84@gmail.com
About this study
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.
Read the 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. 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 lesion by investigator. The lesion was covered with a hydrocolloid dressing fastened with Micropore tape for 6 hours-10 hours (during the night). 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 wart lesions were inspected, measured, and photographed at enrollment, at week 2- 12 during the treatment period, and three to six months after the completion of treatment. The width, length, and height of each lesion were measured with the use of a slide caliper, and the volume of each genital wart lesion was calculated.
If genital warts recur during the first six-week period, CO2 laser treatment will be applied, followed by the continued use of a placebo or Geniwa topical gel. The randomization code was broken after all patients had completed six weeks of the randomly assigned treatment. Geniwa gel is predicted to be 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.
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 any other treatment they had received for genital warts, and about any other illness or treatment in the intervening period.
For patients who experience bleeding or significant wound pain after CO2 laser treatment, Geniwa or placebo topical gel application may not be possible until 1-2 days later.
Additionally, patients who undergo CO2 laser treatment are prescribed oral cefotaxime (for 7 days) and topical Tyrosur gel (Tyrothricin) daily (1-3 days) in the morning to reduce infection and promote wound healing. Tyrosur gel is used at different times of the day than placebo/Geniwa gel.
- Being tested
- Geniwa gel, Placebo gel
- Keywords
- HPV, Genital warts
- Medical subject headings
- Papillomavirus Infections, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geniwa gelDrug
Geniwa gel contains alpha lactalbumin-oleic acid 5%
Placebo gelOther
Placebo gel contains saline
| Study group | Role | What they receive |
|---|---|---|
| Combination of CO2 laser and placebo gel | Placebo comparator | Placebo gel contains saline gel Receives: Other: Placebo gel |
| Combination of CO2 laser and Geniwa gel | Experimental | Geniwa gel contains 5% alpha lactalbumin-oleic acid complexes Receives: Drug: Geniwa gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy
Number of patients with complete elimination of all genital warts lesions at 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.
Measured: 12 weeks of treatment
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 4-6 months after the last 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.
Measured: 1-12 weeks of treatment
Wart lesions
Number of wart lesions/patient
Measured: 1-12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start16 Jul 2026
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV (Human Papillomavirus)-AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTH Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698886
- Sponsor's protocol ID
- NHDV22.26
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 15215482
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
- ClinicalTrials.gov ID
- NCT07698886
- Acronym / sponsor ID
- NHDV22.26
- Keywords
- HPV, Genital warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- KTH BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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 lesion by investigator. The lesion was covered with a hydrocolloid dressing fastened with Micropore tape for 6 hours-10 hours (during the night). 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 wart lesions were inspected, measured, and photographed at enrollment, at week 2- 12 during the treatment period, and three to six months after the completion of treatment. The width, length, and height of each lesion were measured with the use of a slide caliper, and the volume of each genital wart lesion was calculated.
If genital warts recur during the first six-week period, CO2 laser treatment will be applied, followed by the continued use of a placebo or Geniwa topical gel. The randomization code was broken after all patients had completed six weeks of the randomly assigned treatment. Geniwa gel is predicted to be 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.
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 any other treatment they had received for genital warts, and about any other illness or treatment in the intervening period.
For patients who experience bleeding or significant wound pain after CO2 laser treatment, Geniwa or placebo topical gel application may not be possible until 1-2 days later.
Additionally, patients who undergo CO2 laser treatment are prescribed oral cefotaxime (for 7 days) and topical Tyrosur gel (Tyrothricin) daily (1-3 days) in the morning to reduce infection and promote wound healing. Tyrosur gel is used at different times of the day than placebo/Geniwa gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of CO2 laser and placebo gel | Placebo comparator | Other: Placebo gelPlacebo gel contains saline gel |
| Combination of CO2 laser and Geniwa gel | Experimental | Drug: Geniwa gelGeniwa gel contains 5% alpha lactalbumin-oleic acid complexes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Have undergone at least 2 laser or nitrogen treatments and have experienced recurrence in any location.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geniwa gelGeniwa gel contains alpha lactalbumin-oleic acid 5% | Drug | Combination of CO2 laser and Geniwa gel |
| Placebo gelPlacebo gel contains saline | Other | Combination of CO2 laser and placebo gel |
Primary outcome
The efficacy
Time frame: 12 weeks of treatment
Number of patients with complete elimination of all genital warts lesions at 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.
5 secondary outcomes
Partial elimination
Time frame: 1-12 weeks of treatment
New lesions
Time frame: 1 week-6 months
Recurrence rate
Time frame: 4-6 months after the last treatment
The Safety
Time frame: 1-12 weeks of treatment
Wart lesions
Time frame: 1-12 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Results publication: PubMed 15215482Gustafsson 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Geniwa gel in people with HPV (Human Papillomavirus)-Associated and Genital Warts, run by KTH Biopharma at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thanh Tam Tran, MD (+84383744842, Tranthanhtam.fmh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.