Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Methyl aminolevulinate (MAL) PDT

Registration Number: NCT00594425

Lead Sponsor: Photocure

Brief Summary: This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.

Detailed Description: For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light dose of 37 J/cm2. One treatment group will receive vehicle cream, while the other 2 groups will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively. The MAL and vehicle cream will be applied in a thin layer on clean skin and left for 1.5 hours under occlusion before illumination.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

Inclusion Criteria

Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
Patients with skin type I to IV (Fitzpatrick).
Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face excluding lesions on the nose and in the peri-ocular area.
Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
Patients with no more than 2 nodular lesions on the face.
Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to Day 0. Patients using birth control pills must have used the same product and dose for at least 6 months and must agree to stay with the same product and dose for an additional 6 months.
Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
Patients must sign the approved informed consent form prior to any study procedures.
Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.

Exclusion Criteria

Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
Participation in other clinical studies either concurrently or within the last 30 days.
Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
Patients with a washout period for topical treatments for their acne of less than 14 days. Medicated cleansers may be used during the washout period and stopped before the treatment.
Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
Patients with a washout period for oral isotretinoin of less than 6 months.
Patients with a beard or other facial hair that might interfere with study assessments.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Methyl aminolevulinate (MAL) PDT	PDT using Placebo cream
1	Methyl aminolevulinate (MAL) PDT	PDT using MAL concentration A
2	Methyl aminolevulinate (MAL) PDT	PDT using MAL concentration B

Primary Outcome Measures

Name	Time	Method
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment	12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts	12 weeks after last treatment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline	6 weeks after last treatment
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline	6 weeks after last treatment
Proportion of Patients With Severe Erythema After Second Treatment	immediately after second treatment
Proportion of Patients With Severe Erythema After Third Treatment	immediately after third treatment
Percent Reduction in Total Lesion Counts From Baseline	6 weeks after last treatment
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment	6 weeks after last treatment
The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment	12 weeks after last treatment
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.	immediately after illumination-fourth treatment treatment	Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain	immediately after second treatment	Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Proportion of Patients With Mild and Moderate Erythema After First Treatment	2 days after first treatment
Proportion of Patients With Mild and Moderate Erythema After Second Treatment	immediately after second treatment
Proportion of Patients With Mild and Moderate Erythema After Third Treatment	immediately after third treatment
Proportion of Patients With Severe Erythema After Fourth Treatment	immediately after fourth treatment
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment	immediately after fourth treatment
Proportion of Patients With Severe Erythema After First Treatment	immediately after first treatment
Proportion of Patients With Severe Erythema 2 Days After First Treatment	2 days after first treatment
Proportion of Patients With Severe Erythema 7 Days After First Treatment	7 days after first treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment	2 weeks after first treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment	12 weeks after last treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment	2 weeks after first treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment	12 weeks after last treatment

Trial Locations

Locations (14): Dermatology Treatment & Research
🇺🇸
Dallas, Texas, United States
Dermatology Associates of Rochester
🇺🇸
Rochester, New York, United States
Suzanne Bruce and Associates, PA
🇺🇸
Houston, Texas, United States
Therapeutics Clinical Research
🇺🇸
San Diego, California, United States
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
DuPage Medical Group
🇺🇸
Naperville, Illinois, United States
Solano Clinical Research
🇺🇸
Vallejo, California, United States
The Education & Research Foundation, Inc.
🇺🇸
Lynchburg, Virginia, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Michigan Center for Research Corp
🇺🇸
Clinton Twp, Michigan, United States
Central Sooner Research
🇺🇸
Norman, Oklahoma, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
The Dermatology Clinical Research Center of San Antonio
🇺🇸
San Antonio, Texas, United States
Dermatology Research Center, Inc.
🇺🇸
Salt Lake City, Utah, United States