Clinical trial • Phase II • Dermatology
METFORMIN EMBONATE for Actinic keratosis
Phase II trial of METFORMIN EMBONATE for Actinic keratosis.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Actinic keratosis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-01-2025
- First CTIS Authorization Date
- 30-01-2025
Trial design
Randomised, dpdt with methyl aminolevulinate (mal) as monotherapy (mal topical formulation) versus adjuvant topical metformin combined with dpdt with mal; placebo topical composition specified as propylene glycol, neopclo/w, fenonip xb and purified water. no specific doses/schedules beyond topical use and single mal application details provided.-controlled Phase II trial across 3 sites in Spain.
- Randomised
- Yes
- Comparator
- dPDT with methyl aminolevulinate (MAL) as monotherapy (MAL topical formulation) versus adjuvant topical metformin combined with dPDT with MAL; placebo topical composition specified as propylene glycol, neoPCLO/W, fenonip XB and purified water. No specific doses/schedules beyond topical use and single MAL application details provided.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 135
- Trial Duration For Participant
- 336
Eligibility
Recruits 135 No vulnerable populations selected; subjects must be over 18 years of age; no specific consent/assent handling for vulnerable or paediatric participants is described..
- Pregnancy Exclusion
- Pregnant or breastfeeding women.
- Vulnerable Population
- No vulnerable populations selected; subjects must be over 18 years of age; no specific consent/assent handling for vulnerable or paediatric participants is described.
Inclusion criteria
- {"criterion_text":"- Males or females over 18 years of age."}
- {"criterion_text":"- Subjects with at least 5 actinic keratoses on face and/or scalp Olsen grade I and/or II (Olsen, 1991)."}
- {"criterion_text":"- If women of childbearing capacity participate, they must use an effective method of contraception throughout the study."}
Exclusion criteria
- {"criterion_text":"- Patients with predominantly Olsen grade 3 actinic keratoses."}
- {"criterion_text":"- Have been treated for your actinic keratosis with surgery, cryotherapy, laser, radiotherapy, electrosurgery, 5-fluorouracil, diclofenac, imiquimod or retinoids 4 weeks previously."}
- {"criterion_text":"- Treatment with oral retinoids or nicotinamide in the previous 12 weeks."}
- {"criterion_text":"- Patients on oral treatment with metformin."}
- {"criterion_text":"- Patients with severe renal, hepatic and cardiac disease in whom oral metformin is contraindicated."}
- {"criterion_text":"- Patients with porphyria."}
- {"criterion_text":"- Patients with systemic diseases that may interfere with the results of the study."}
- {"criterion_text":"- Patients who are not expected to be able to follow the indications of the study."}
- {"criterion_text":"- Patients with hypersensitivity to any of the study drugs."}
- {"criterion_text":"- Immunosuppressed patients."}
- {"criterion_text":"- Pregnant or breastfeeding women."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Patients will receive treatment for 12 weeks and will be observed for 36 weeks after completion of treatment to assess clinical efficacy and adverse effects.","definition_or_measurement_approach":"Treatment duration: 12 weeks; follow-up observation: 36 weeks after completion of treatment; clinical efficacy and adverse effects will be assessed during and after this period."}
Recruitment
- Planned Sample Size
- 135
- Recruitment Window Months
- 9
- Consent Approach
- Informed consent obtained from adult participants (participants aged >18). Subject information and informed consent form available in Spanish (document L1_SIS and ICF_es). No paediatric assent procedures described.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 135
Spain
- Earliest CTIS Part Ii Submission Date
- 25-01-2025
- Latest Decision Or Authorization Date
- 30-01-2025
- Processing Time Days
- 5
- Number Of Sites
- 3
- Number Of Participants
- 135
Sites
- Site Name
- Hospital Universitario Fundacion Alcorcon
- Department Name
- Dermatology
- Contact Person Name
- Ana Pampín
- Contact Person Email
- ana_pampin@hotmail.com
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Dermatology
- Contact Person Name
- Yolanda Gilaberte
- Contact Person Email
- ygilaberte@gmail.com
- Site Name
- Hospital General Universitario De Ciudad Real
- Department Name
- Dermatology
- Contact Person Name
- Juan Luis Santiago
- Contact Person Email
- jlsantiago18@yahoo.es
Sponsor
Primary sponsor
- Full Name
- Fundacion Instituto De Investigacion Sanitaria Aragon
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- METFORMIN
- Active Substance
- METFORMIN EMBONATE
- Modality
- Small molecule
- Routes Of Administration
- TOPICAL ADMINISTRATION
- Route
- TOPICAL ADMINISTRATION
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Maximum Dose
- 2 DF dosage form (maxDailyDoseAmount); 168 DF dosage form (maxTotalDoseAmount)
- Investigational Product Name
- The placebo components are propylene glycol, neoPCLO/W, fenonip XB and purified water.
- Modality
- Other
- Investigational Product Name
- METHYL AMINOLEVULINATE
- Active Substance
- METHYL AMINOLEVULINATE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- TOPICAL ADMINISTRATION
- Route
- TOPICAL ADMINISTRATION
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Starting Dose
- 1 DF dosage form
- Maximum Dose
- 1 DF dosage form (maxTotalDoseAmount)
- Combination Treatment
- Yes
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