Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 5:07 AM
Study NCT ID:
NCT01689935
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced Side-Effects of Photodynamic Therapy for the Treatment of Moderate to Severe Acne (i-PDT)
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Pilot Clinical Trial to Reduce Side-Effects of Photodynamic Therapy for the Treatment of Moderate to Severe Acne
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
i-PDT
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: