Moderate inflammatory acne vulgaris.
Conditions
Interventions
Trade Name: Metvix 160 mg/g cream
Product Name: Metvix 160 mg/g cream
Product Code: P-1202
Pharmaceutical Form: Cream
CAS Number: 79416-27-6
Current Sponsor code: P-1202
Other descriptive name: Methyl
Sponsors
PhotoCure ASA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects of any race, age 15 to 35 years inclusive, with moderate, inflammatory, facial acne vulgaris (Leeds score 5-10). Female subjects must present a negative pregnancy test before each treatment. 2. Subjects with skin type 1-3 (Fitzpatrick). 3. Subjects with a minimum of 10 inflammatory lesions (papules and pustules) on the face. 4. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose. 5. Subjects (and parent/guardian if subject is under 18 years of age) must be willing and capable of following study instructions to the extent and degree required by the protocol. 6. Subjects 18 years and older must sign the approved Informed Consent Form prior to any study procedures. Subjects under the age of 18 years must read the subject information sheet and sign the informed consent form, and must have a parent or guardian read the same subject information sheet and sign an identical informed consent form prior to undergoing any study procedures. 7. Subjects must be willing to be photographed. Subjects (and parent/guardian if subject is under 18 years of age) must be willing to sign a Photography Consent Form. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with porphyria. 2. Subjects with skin type 4-6 (Fitzpatrick). 3. Known allergy to Metvix®, a similar PDT compound or excipients of the cream. 4. Participation in other clinical studies either concurrently or within the last 30 days. 5. Subjects with more than three nodulo-cystic lesions. 6. Subjects with a condition or who are in a situation, which, in the Investigator’s opinion, may put the Subject at risk, may confound the study results, or may interfere with the Subject’s participation in the study. 7. Subjects with a wash-out period for topical treatment on the face less than: 2 weeks: Corticosteroids, antibiotics, antiseptics, retinoids, other anti-inflammatory drugs, or other acne treatments. 1 week: Zinc containing drugs. 8. Subjects with a wash-out period for systemic treatment less than: 4 weeks: Corticosteroids, antibiotics. 3 months: Spironolactone, other acne treatments (including isotretinoin). NOTE: Oral vitamin A up to the recommended daily dose, 4000-5000 IU, is acceptable. 9. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.). 10. Subjects with a beard or other facial hair that might interfere with study assessments. 11. Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc…).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to evaluate efficacy and safety of photodynamic therapy (PDT) with Metvix 160 mg/g cream compared to placebo in subjects with moderate inflammatory acne vulgaris in the face. The primary endpoint is the percent reduction in inflammatory lesion count from baseline. ;Secondary Objective: The secondary endpoints are: - The percent reduction in total lesion count from baseline - The percent reduction in non-inflammatory lesion count from baseline - The Investigator global assessment of improvement from baseline - Local tolerance scores and recording of adverse events. ;Primary end point(s): The primary endpoint is the percent reduction in inflammatory lesion count from baseline. | — |
Countries
Sweden
Outcome results
None listed