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

Photocure150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Acne Vulgaris

Interventions

Methyl aminolevulinate (MAL) PDTDRUG

Cream application followed by illumination with red light

Eligibility

Sex: ALLMin age: 15 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4). 2. Patients with skin type I to IV (Fitzpatrick). 3. 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. 4. Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face. 5. Patients with no more than 2 nodular lesions on the face. 6. 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. 7. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol. 8. Patients must sign the approved informed consent form prior to any study procedures. 9. Patients must be willing to be photographed. Patients must be willing to sign a photography consent form. Exclusion Criteria: 1. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream. 2. Participation in other clinical studies either concurrently or within the last 30 days. 3. 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. 4. Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity. 5. Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days. 6. 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. 7. Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month. 8. Patients with a washout period for oral isotretinoin of less than 6 months. 9. Patients with a beard or other facial hair that might interfere with study assessments.

Locations (14)

Therapeutics Clinical Research

San Diego, California, United States

Solano Clinical Research

Vallejo, California, United States

DuPage Medical Group

Outcomes

Primary Outcomes

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

Time frame: 12 weeks after last treatment

Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts

Time frame: 12 weeks after last treatment

Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

Time frame: 12 weeks

Secondary Outcomes

Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

Time frame: 3 weeks after last treatment

Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

Time frame: 6 weeks after last treatment

Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline

Time frame: 6 weeks after last treatment

Percent Reduction in Total Lesion Counts From Baseline

Time frame: 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

Time frame: 6 weeks after last treatment

The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment

Time frame: 12 weeks after last treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Naperville, Illinois, United States

Michigan Center for Research Corp

Clinton Twp, Michigan, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Dermatology Associates of Rochester

Rochester, New York, United States

Central Sooner Research

Norman, Oklahoma, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Dermatology Treatment & Research

Dallas, Texas, United States

Suzanne Bruce and Associates, PA

Houston, Texas, United States

...and 4 more locations

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Time frame: immediately after illumination-first treatment

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Time frame: immediately after second treatment

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Time frame: immediately after third treatment

Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm

Time frame: immediately after illumination-fourth treatment treatment

Proportion of Patients With Mild and Moderate Erythema After First Treatment

Time frame: immediately after first treatment

Proportion of Patients With Mild and Moderate Erythema After First Treatment

Time frame: 2 days after first treatment

Proportion of Patients With Mild and Moderate Erythema After Second Treatment

Time frame: immediately after second treatment

Proportion of Patients With Mild and Moderate Erythema After Third Treatment

Time frame: immediately after third treatment

Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment

Time frame: immediately after fourth treatment

Proportion of Patients With Severe Erythema After First Treatment

Time frame: immediately after first treatment

Proportion of Patients With Severe Erythema 2 Days After First Treatment

Time frame: 2 days after first treatment

Proportion of Patients With Severe Erythema 7 Days After First Treatment

Time frame: 7 days after first treatment

Proportion of Patients With Severe Erythema After Second Treatment

Time frame: immediately after second treatment

Proportion of Patients With Severe Erythema After Third Treatment

Time frame: immediately after third treatment

Proportion of Patients With Severe Erythema After Fourth Treatment

Time frame: immediately after fourth treatment

Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment

Time frame: 2 days after treatment

Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment

Time frame: 2 weeks after first treatment

Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

Time frame: 2 weeks after last treatment

Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

Time frame: 6 weeks after last treatment

Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

Time frame: 12 weeks after last treatment

Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment

Time frame: 2 days after first treatment

Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

Time frame: 2 weeks after last treatment

Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment

Time frame: 2 weeks after first treatment

Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

Time frame: 6 weeks after last treatment

Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

Time frame: 12 weeks after last treatment