Daylight-PDT With MAL for AK and Photodamaged Skin

• Status: Completed
• Trial end date: 2018-09-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Regensburg
• Treatments: Aminolevulinic Acid; Methyl 5-aminolevulinate

Criteria

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 during 6 months preceding study treatment

• Non-permitted medication:

• Topical treatment in the face during 4 weeks preceding study treatment with diclofenac, hydrochinone, peeling, 5-FU, ingenolmebutate, retinoids, podophyllin, azelaic acid, imiquimod or other agents, that could interfere with the evaluation of the efficacy of the study treatment, according to the investigator.

• Systemic treatment with retinoids

• Conditions that might interfere with the ability to understand the study and thus give written informed consent

• Rejuvenating treatments of the face during 3 months preceding study treatment, including filler, botulinumtoxin and IPL