Status:
COMPLETED
Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne
Lead Sponsor:
Photocure
Conditions:
Acne
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Photocure ASA has developed a cream formulation containing methyl aminolevulinate (MAL), an ester of ALA. There is extensive experience with the safety of MAL-PDT in humans. This study will assess sa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00833183
Start Date
July 1 2007
End Date
July 1 2008
Last Update
January 30 2009
Active Locations (2)
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1
Innovaderm Research Inc
Laval, Quebec, Canada, H7S 2C6
2
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5