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

NCT01689935 | Completed Phase 1 DMC

• 1 other identifier: 2009-P-002352
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Keywords

Acne vulgaris; Photodynamic Therapy; Side-effects; Pain

Outcome Measures

Primary Outcomes (1)

• Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris

  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.

  0, 4, 8, 12, 16, 24 and 36 weeks

Secondary Outcomes (1)

• Pain reduction

  During, immediately after and 24 h after treatment

Other Outcomes (1)

• Side-effects Profile

  Immediately after treatment and during follow-up visits

Study Arms (5)

Control

NO INTERVENTION

No drug, no treatment

ALA-PDT

ACTIVE COMPARATOR

Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT

Drug: 20 % Aminolevulinic Acid

i-PDT

EXPERIMENTAL

Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy

Drug: 20 % Aminolevulinic Acid; Device: Blue light only

Red Light only

ACTIVE COMPARATOR

Red light only - no drug

Device: Red light only

Blue light only

ACTIVE COMPARATOR

Blue light only - no drug

Device: Blue light only

Interventions

20 % Aminolevulinic Acid DRUG

topical medication for ALA-PDT and i-PDT

Also known as: 5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)

ALA-PDT; i-PDT

Red light only DEVICE

Red Light therapy

Also known as: Omnilux Revive, 635 nm - LED (Phototherapeutics, Cheshire, UK)

Red Light only

Blue light only DEVICE

Blue light only

Also known as: Omnilux Blue, 415 nm LED (Phototherapeutics, Cheshire, UK)

Blue light only; i-PDT

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects with ages between 14 and 50 years, male or female.
• Subjects with severe acne lesions (one or more nodules or cysts present) on their backs or face
• Presence of moderate acne on the back and/or face that has been recalcitrant to previous treatments. Recalcitrant acne is acne with no or mild/temporary (less than 3 months) improvement after using:
• Accutane® for at least one completed treatment cycle, and/or
• Oral antibiotic for ≥ 3 months; and/or
• Topical prescription retinoids (tretinoin - retinoic acid, adapalene, tazarotene or other derivatives) for ≥ 3 months, and/or
• Topical benzoyl peroxide 2.5% or higher concentrations for ≥ 3 months
• Hormonal treatments\*\* for ≥ 3 months.
• Willingness to participate in the study
• Willingness to receive ALA-PDT treatment
• Informed consent agreement signed by the subject
• Willingness to follow the treatment schedule and post treatment care requirements
• Willingness to not use topical or systemic (oral) anti-acne medications including medicated shampoo or soap during the study period.

You may not qualify if:

• Subjects receiving concurrent oral retinoids or antibiotics
• \*\* Subjects with chronic use of antibiotics may be included if proven that its use has not changed the severity of their acne. AND
• \*\*\* Chronic use of antibiotic is considered ≥ 2 years of continuous use.
• Scarring or infection of the area to be treated
• Known photosensitivity
• Presence of suntan in the area to be treated
• Subjects who have taken medication known to induce photosensitivity in the previous 3 months
• Subjects who have had prior oral retinoid (Accutane®) use within 6 months of entering the study
• Topical antibiotic or other topical anti-acne treatments use within 2 weeks of entering the study
• Known anticoagulation or thromboembolic condition
• Subjects who are immunosuppressed
• Subject is unable to comply with treatment, home care or follow-up visits
• Subject is pregnant or breast feeding
• Subject has a history of being on photosensitive medications (thiazides \[used to treat high blood pressure\], tetracyclines, fluoroquinolones griseofulvin or sulfonamides \[used to treat infections\], sulfonylureas \[used to treat diabetes\], calcium channel blockers \[used to treat hypertension\]. phenothiazines \[used to treat serious emotional problems\]).
• Known skin sensitivity to blue light

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Acne Vulgaris; Pain

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Harvard Medical School (Dermatology)

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: September 21, 2012
• Study Start: November 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 20, 2025

Record last verified: 2019-09