Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00594425

Acne Vulgaris

COMPLETED PHASE2

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

NCT00833183

Acne

COMPLETED PHASE2

Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for Moderate and Severe Acne Vulgaris

NCT04167982

Acne

UNKNOWN NA

Reduced Side-Effects of Photodynamic Therapy for the Treatment of Moderate to Severe Acne (i-PDT)

NCT01689935

Acne Vulgaris

COMPLETED PHASE1

Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)

NCT02464709

Actinic Keratosis Natural Daylight Photodynamic Therapy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.

Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

PDT using MAL crem

Group Type EXPERIMENTAL

Methyl aminolevulinate (MAL) PDT

Intervention Type DRUG

Cream application followed by illumination with red light

2

PDT using Placebo cream

Group Type PLACEBO_COMPARATOR

Methyl aminolevulinate (MAL) PDT

Intervention Type DRUG

Cream application followed by illumination with red light

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methyl aminolevulinate (MAL) PDT

Cream application followed by illumination with red light

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Female and male patients, age 15 to 40 years with acne vulgaris.
2. Patients with skin type V or VI (Fitzpatrick).
3. Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm.
4. Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
5. 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 3 months and must agree to stay with the same product and dose for an additional 3 months.
6. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
7. Patients must sign the approved informed consent form prior to any study procedures.
8. 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) within the last 30 days.
6. Patients with a washout period for topical treatments for their acne in the two treatment areas of less than 14 days. Any topical treatment on the face or other areas outside the two treatment areas will be allowed.
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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No