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

Photocure

Status and phase: Completed; Phase 2

Conditions: Acne

Treatments: Drug: MAL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833183

INNO-6005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 4 patient groups

25 J/cm2, with occlusion on right side

Active Comparator group

Description:

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.

Treatment:

Drug: MAL

37 J/cm2, with occlusion on right side

Active Comparator group

Description:

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.

Treatment:

Drug: MAL

25 J/cm2 , with occlusion on left side

Active Comparator group

Description:

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.

Treatment:

Drug: MAL

37 J/cm2 , with occlusion on left side

Active Comparator group

Description:

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.

Treatment:

Drug: MAL