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

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: 20 % Aminolevulinic Acid; Device: Red light only; Device: Blue light only

• Registration Number: NCT01689935
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2009-11-01
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Primary Completion: 2013-09-01
• Study Completion: 2014-12-01
• Status Verified: 2019-09
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALA-PDT	20 % Aminolevulinic Acid	Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT
i-PDT	20 % Aminolevulinic Acid	Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy
i-PDT	Blue light only	Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy
Red Light only	Red light only	Red light only - no drug
Blue light only	Blue light only	Blue light only - no drug

Primary Outcome Measures

Name	Time	Method
Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris	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 Outcome Measures

Name	Time	Method
Pain reduction	During, immediately after and 24 h after treatment	Visual Pain Scale - 0 (no pain) -10 (severe pain)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States