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Randomised study to evaluate metformin as an enhancer treatment and also to find out if it is effective and safe in daylight therapy for skin lesions.
EU CTIS ID: 2025-520798-38-00
What this study is testing
To determine the efficacy and safety of topical metformin as an adjuvant to daylight photodynamic therapy (dPDT) with methyl aminolevulinate (MAL) in the treatment of actinic keratoses and the cancerisation field.
- Therapeutic exploratory (Phase II)
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
- Males or females over 18 years of age.
- Subjects with at least 5 actinic keratoses on face and/or scalp Olsen grade I and/or II (Olsen, 1991).
- If women of childbearing capacity participate, they must use an effective method of contraception throughout the study.
You likely can't join if
- Patients with predominantly Olsen grade 3 actinic keratoses.
- Immunosuppressed patients.
- Pregnant or breastfeeding women.
- Have been treated for your actinic keratosis with surgery, cryotherapy, laser, radiotherapy, electrosurgery, 5-fluorouracil, diclofenac, imiquimod or retinoids 4 weeks previously.
- Treatment with oral retinoids or nicotinamide in the previous 12 weeks.
- Patients on oral treatment with metformin.
See the full eligibility criteria
- Males or females over 18 years of age.
- Subjects with at least 5 actinic keratoses on face and/or scalp Olsen grade I and/or II (Olsen, 1991).
- If women of childbearing capacity participate, they must use an effective method of contraception throughout the study.
- Patients with predominantly Olsen grade 3 actinic keratoses.
- Immunosuppressed patients.
- Pregnant or breastfeeding women.
- Have been treated for your actinic keratosis with surgery, cryotherapy, laser, radiotherapy, electrosurgery, 5-fluorouracil, diclofenac, imiquimod or retinoids 4 weeks previously.
- Treatment with oral retinoids or nicotinamide in the previous 12 weeks.
- Patients on oral treatment with metformin.
- Patients with severe renal, hepatic and cardiac disease in whom oral metformin is contraindicated.
- Patients with porphyria.
- Patients with systemic diseases that may interfere with the results of the study.
- Patients who are not expected to be able to follow the indications of the study.
- Patients with hypersensitivity to any of the study drugs.
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, 65+ years, 18-64 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.