Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A study of safety and efficacy of topical methyaminlevulinate 80mg/g with and without occlusion followed by red light exposure in subjects with facial acne.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Photocure

Criteria

Inclusion Criteria:

• Subject willing to use an adequate contraceptive method or is surgically sterile, post menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; IUD in use 30 days prior to day 0, barrier methods and spermicide in use atleast 14 days prior to day 0 or oral contraceptive in use for at least 6 months prior to day 0

• Age 18 or older

• Capable of giving informed consent

• Diagnosis of acne vulgaris on the face with at least 10 inflammatory lesions on both sides of the face at screening and day 0

• Global acne severity assessment score ≥ 3 at the screening and day 0 visit.

Exclusion Criteria:

• Allergy to methylaminolevulinate or any component of the vehicle

• Acne fulminans or conglobata on the face

• Clinical significant sensitivity to visible light, porphyria or porphyrin sensitivity

• Use of any topical treatment for acne on the face within the previous 2 weeks before day 0

• Any use of systemic antibiotics within 1 month prior to day 0 or use of isotretinoin within 1 year prior to Day 0

• Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within 4 weeks of Day 0

• Use of any investigational drug within 4 weeks of Day 0

• Alcoholism or drug abuse in the past year

• Any unstable or serious medical condition at the discretion of the investigator

• Current pregnancy or lactation

• Use of hormonal contraceptives solely for control of acne

• Current use of oral contraceptives (unless subject is on a stable dose e.i. at least six months of treatment prior Day 0), testosterone or any other systemic hormonal treatment

• Any serious dermatological disorder, including malignancies that would either put the subject at risk or interfere with efficacy or safety evaluations

• Fitzpatrick phototype V or VI (inadequate penetration of red light in dark skin subjects)

• Subjects with extensive facial hair (e.g. beard) that would either impair red light exposure or interfere with lesion evaluation.