Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne - Full Text View

Sponsored by:	PhotoCure
Information provided by:	PhotoCure
ClinicalTrials.gov Identifier:	NCT00833183

Purpose

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.

Condition	Intervention	Phase
Acne	Drug: MAL	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of Safety and Efficacy of Topical Methylaminolevulinate 80mg/g With and Without Occlusion Followed by Red Light Exposure in Subjects With Facial Acne

Resource links provided by NLM:

MedlinePlus related topics: Acne

U.S. FDA Resources

Further study details as provided by PhotoCure:

Primary Outcome Measures:

To compare the number of inflammatory acne lesions according to time on the side with occlusion and the side without occlusion for subjects with facial acne vulgaris exposed to 25 J/cm2 and 37 J/cm2 of red light. [ Time Frame: 4 and 12 weeks after last PDT session. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exposed to 25 J/cm2 and 37 J/cm2 of red light and with and withut occlusion :-Compare number of non-inflammatory acne lesions. -Safety assesment of MAL-PDT. -Evaluate PAP photobleaching. [ Time Frame: At each treatment visit and 2 and 7 days after first PDT treatment visit. ] [ Designated as safety issue: Yes ]

Enrollment:	44
Study Start Date:	July 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
25 J/cm2, with occlusion on right side: Active Comparator Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g). Occlusion will be applied to one half of the face. After an incubation time of 90 minutes both sides of the face will be exposed to either 25 J/cm2 of red light starting with the occluded side first.	Drug: MAL 80 mg/g cream one administration with incubation for 90 minutes
37 J/cm2, with occlusion on right side: Active Comparator Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g). Occlusion will be applied to one half of the face. After an incubation time of 90 minutes both sides of the face will be exposed to 37 J/cm2 of red light starting with the occluded side first.	Drug: MAL 80 mg/g cream one administration with incubation for 90 minutes
25 J/cm2 , with occlusion on left side: Active Comparator Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g). Occlusion will be applied to one half of the face. After an incubation time of 90 minutes both sides of the face will be exposed to either 25 J/cm2 of red light starting with the occluded side first.	Drug: MAL 80 mg/g cream one administration with incubation for 90 minutes
37 J/cm2 , with occlusion on left side: Active Comparator Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g). Occlusion will be applied to one half of the face. After an incubation time of 90 minutes both sides of the face will be exposed to 37 J/cm2 of red light starting with the occluded side first.	Drug: MAL 80 mg/g cream one administration with incubation for 90 minutes

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 safety and efficacy of four treatments with methylaminolevulinate (MAL) at 80 mg/g performed with and without occlusion and followed by red light exposure 90 minutes later in subjects with facial acne vulgaris. Subjects will be randomized to one of two groups of 20 subjects: Group 1 will receive 25 J/cm2 of red light (45 mW/cm2) and group 2 will receive 37 J/cm2 of red light (90 mW/cm2). For each subject one side of the face will be randomized to receive MAL for 90 minutes without occlusion and the other side of the face will receive MAL for 90 minutes with occlusion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833183

Locations

Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Innovaderm Research Inc
Laval, Quebec, Canada, H7S 2C6

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

Robert Bissonnette, MD MSC FRCPC

Innovaderm Research Inc.

More Information

No publications provided

Responsible Party:	Photocure ( Per Fuglerud )
Study ID Numbers:	INNO-6005
Study First Received:	January 29, 2009
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00833183 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Skin Diseases

Facies
Sebaceous Gland Diseases
Acne Vulgaris

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Acneiform Eruptions
Sebaceous Gland Diseases
Acne Vulgaris

ClinicalTrials.gov processed this record on August 28, 2009