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

Primary Purpose

Acne

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
MAL
Sponsored by
Photocure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Innovaderm Research Inc
  • Innovaderm Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

25 J/cm2, with occlusion on right side

37 J/cm2, with occlusion on right side

25 J/cm2 , with occlusion on left side

37 J/cm2 , with occlusion on left side

Arm 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.

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.

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.

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.

Outcomes

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.

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.

Full Information

First Posted
January 29, 2009
Last Updated
January 29, 2009
Sponsor
Photocure
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1. Study Identification

Unique Protocol Identification Number
NCT00833183
Brief Title
Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Photocure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25 J/cm2, with occlusion on right side
Arm Type
Active Comparator
Arm 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.
Arm Title
37 J/cm2, with occlusion on right side
Arm Type
Active Comparator
Arm 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.
Arm Title
25 J/cm2 , with occlusion on left side
Arm Type
Active Comparator
Arm 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.
Arm Title
37 J/cm2 , with occlusion on left side
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
MAL
Intervention Description
80 mg/g cream one administration with incubation for 90 minutes
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD MSC FRCPC
Organizational Affiliation
Innovaderm Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research Inc
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7S 2C6
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada

12. IPD Sharing Statement

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

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