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

NCT01689935 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

20 % Aminolevulinic Acid

topical medication for ALA-PDT and i-PDT

DEVICE

Red light only

Red Light therapy

DEVICE

Blue light only

Blue light only

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-01
Primary Completion
2013-09-01
Completion
2014-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01689935 on ClinicalTrials.gov