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

NCT00833183 | Completed Phase 2

• 1 other identifier: INNO-6005
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• 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.

  4 and 12 weeks after last PDT session.

Secondary Outcomes (1)

• 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.

  At each treatment visit and 2 and 7 days after first PDT treatment visit.

Study Arms (4)

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

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

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

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

Interventions

MAL DRUG

80 mg/g cream one administration with incubation for 90 minutes

25 J/cm2 , with occlusion on left side; 25 J/cm2, with occlusion on right side; 37 J/cm2 , with occlusion on left side; 37 J/cm2, with occlusion on right side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Photocure: lead

Study Sites (2)

Innovaderm Research Inc

Laval, Quebec, H7S 2C6, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Robert Bissonnette, MD MSC FRCPC

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: January 30, 2009
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

CA (2)