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Efficacy and Safety of Cryotherapy followed by Tirbanibulin ointment for actinic keratosis on the scalp and forehead
EU CTIS ID: 2023-509931-15-00
What this study is testing
Assess the efficacy at 8 months of a combined approach associating cryotherapy and tirbanibulin, repeated at 4 months (only if persistent keratosis with regard to cryotherapy) on actinic keratosis of the scalp.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient ≥ 18 years old with Scalp containing ≥ 8 typical, clinically visible or palpable grade I or II actinic keratosis with at least 4 actinic keratosis per hemi-scalp.
- Patient who, according to the investigator's opinion, are in good general condition (WHO ≤2).
- The actinic keratosis must be distributed in 2 non-overlapping zones of similar grade.
- Patient able to understand and agree to the study visit schedule and other protocol requirements.
- Patient able to understand and voluntarily sign an informed consent form.
- Patient with social insurance.
You likely can't join if
- Actinic keratosis clinically atypical and/or rapidly progressive in the treatment area, and grade 3 actinic keratosis according to Olsen's classification.
- A defined treatment area, which would be : - On an area other than the scalp and/or forehead. - Within 5 cm of a wound that has not completely healed or a lesion suspected of containing carcinoma.
- Previous treatment with Tirbanibulin.
- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatment for actinic keratosis in the treatment area, or within 2 cm around this area, in the 6 weeks prior to the screening visit.
- Use of the following therapies within 2 weeks prior to the screening visit: - Therapeutic or cosmetic procedures (e.g. use of liquid nitrogen, surgical excision, dermabrasion, medium or deep chemical peel, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area. - Therapeutic products containing acid (e.g. salicylic acid, fruit acids, etc.), topical retinoids, or light peels in the treatment area or within 2 cm around the selected treatment area.
- Allergy to tirbanibulin or any of its components.
See the full eligibility criteria
- Patient ≥ 18 years old with Scalp containing ≥ 8 typical, clinically visible or palpable grade I or II actinic keratosis with at least 4 actinic keratosis per hemi-scalp.
- Patient who, according to the investigator's opinion, are in good general condition (WHO ≤2).
- The actinic keratosis must be distributed in 2 non-overlapping zones of similar grade.
- Patient able to understand and agree to the study visit schedule and other protocol requirements.
- Patient able to understand and voluntarily sign an informed consent form.
- Patient with social insurance.
- Patient willing to comply with all study procedures and study duration.
- Actinic keratosis clinically atypical and/or rapidly progressive in the treatment area, and grade 3 actinic keratosis according to Olsen's classification.
- A defined treatment area, which would be : - On an area other than the scalp and/or forehead. - Within 5 cm of a wound that has not completely healed or a lesion suspected of containing carcinoma.
- Previous treatment with Tirbanibulin.
- Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatment for actinic keratosis in the treatment area, or within 2 cm around this area, in the 6 weeks prior to the screening visit.
- Use of the following therapies within 2 weeks prior to the screening visit: - Therapeutic or cosmetic procedures (e.g. use of liquid nitrogen, surgical excision, dermabrasion, medium or deep chemical peel, laser resurfacing) in the treatment area or within 2 cm around the selected treatment area. - Therapeutic products containing acid (e.g. salicylic acid, fruit acids, etc.), topical retinoids, or light peels in the treatment area or within 2 cm around the selected treatment area.
- Allergy to tirbanibulin or any of its components.
- Any pathology entailing a risk of poor compliance.
- Administrative reasons: inability to receive informed information, inability to take part in the entire study, lack of social security cover, refusal to sign consent, etc.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.