CompletedPhase 4

Daylight-PDT With MAL for AK and Photodamaged Skin

Germany58 participantsStarted 2016-03-03

Plain-language summary

This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.

Who can participate

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent has been signed prior to or at Screening Visit * Male and female patients with Fitzpatrick skin type I-IV * Age \> 40 years * Negative pregnancy test in women of childbearing age * Women in child-bearing age using highly efficient contraceptive methods (\<1% failure rate per year) * Clinical diagnosis of actinic keratosis (AK) * A minimum of five non-hyperkeratotic, non-pigmented AK lesions in the face. * Glogau Photodamage Classification Type II (moderate) - IV (severe) Exclusion Criteria: * Diagnosis of porphyria * Hyperkeratotic or pigmented AK in the face * Malignant skin tumors in the face or on the capillitium, requiring treatment * Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients * Pregnancy or lactation * Planned aesthetic treatments in the face in the next 24 months (filler, peeling, botulinumtoxin, skin resurfacing) * Known intolerance or allergy to MAL or to any other ingredient of Metvix® 160mg/g cream * Known intolerance to Actinica® lotion * Photosensitivity * Suspected lack of compliance (e.g. due to dementia) * Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion * Concomitant UV-phototherapy * Skin diseases that might interfere with response evaluation of study treatment * Skin sun sensitivity type V or VI according to Fitzpatrick * PDT in the face…

What they're measuring

The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment).

Timeframe: 24 months after the first treatment

Trial details

NCT IDNCT02736760

SponsorUniversity Hospital Regensburg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-09