A Pilot Clinical Trial to Reduce Side-Effects of Photodynamic Therapy for the Treatment of Moderate to Severe Acne
Overview
- Phase
- Phase 1
- Intervention
- 20 % Aminolevulinic Acid
- Conditions
- Acne Vulgaris
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 35
- Primary Endpoint
- Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This research study aims to compare different methods for helping difficult to treat or scarring (cystic) acne, ALA-PDT and i-PDT.
There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.
Levulan® is applied directly to facial/back acne. This is the way that it is usually applied. Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where the Levulan® was applied is exposed to a red light for activation.
The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin through the skin pores to where the glands are. PDT destroys the glands reducing the acne lesion.
Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure also has some side effects. Some of the side effects include pain, burning sensation during the procedure, and redness, tenderness, and swelling after the procedure.
At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT is aimed at reducing the side-effects of ALA- PDT.
The difference between these two procedures is that i-PDT uses a light source that will prevent Levulan® accumulation in the normal skin surface. The investigators would like to find out if Levulan® will be placed only inside the sebaceous glands.
Detailed Description
This is a pilot study to compare efficacy and side effects i-PDT and ALA-PDT. All subjects will receive ALA-PDT and i-PDT. Face or back regions will be divided into two sides, the right and left. One half of the face or back will receive ALA-PDT and the other half will receive i-PDT. For subjects with back acne, red light and blue light alone will be applied for comparison. Healthy subjects with difficult to treat moderate or severe acne on the face or back are eligible to enroll. The investigators will enroll about 35 patients at Massachusetts General Hospital (MGH) with follow-ups 1, 3 and 6 months after treatment.
Investigators
Richard Rox Anderson, MD
Professor, Harvard Medical School (Dermatology)
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ALA-PDT
Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT
Intervention: 20 % Aminolevulinic Acid
i-PDT
Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy
Intervention: 20 % Aminolevulinic Acid
i-PDT
Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy
Intervention: Blue light only
Red Light only
Red light only - no drug
Intervention: Red light only
Blue light only
Blue light only - no drug
Intervention: Blue light only
Outcomes
Primary Outcomes
Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris
Time Frame: 0, 4, 8, 12, 16, 24 and 36 weeks
0. Clear: No lesions but erythema and residual hyperpigmentation may be present 1. Almost Clear: few scattered comedones and a few (\< five) small papules 2. Mild:\< 50% face involved, many comedones/papules and pustules 3. Moderate:\> 50% of face involved. Numerous comedones, papules and pustules 4. Severe: Entire face is covered with comedones, numerous papules and pustules and a few nodules and cysts. 1) Clear or almost clear (Grades 0 or 1) as success at 12 weeks. 2) Two grade improvement as success at 12 weeks.
Secondary Outcomes
- Pain reduction(During, immediately after and 24 h after treatment)