Non-cutting Laser Therapy in the Treatment of Acne

NCT00113425 | Completed Phase 2 Results

• 1 other identifier: Derm 548
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. The use of non-ablative laser therapy, together with application of a photo-sensitizer (substance that makes the skin more sensitive to light), may improve the appearance of acne. The idea behind the photo-sensitizer is that it is supposed to make the laser more effective than using just the laser alone. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne, as well as how much the photo-sensitizer actually enhances the efficacy of the laser.

Conditions

Acne Vulgaris

Keywords

non-ablative laser; acne; photosensitizer; photodynamic therapy

Outcome Measures

Primary Outcomes (7)

• Change From Baseline in Papule Acne Lesions at Week 10

  Baseline and Week 10

• Change From Baseline in Pustule Acne Lesions at Week 10

  Baseline and Week 10

• Change From Baseline in Cysts at Week 10

  Baseline and Week 10

• Change From Baseline in Closed Comedones at Week 10

  Baseline and Week 10

• Change From Baseline in Open Comedones at Week 10

  Baseline and Week 10

• Change From Baseline in Erythematous Macules at Week 10

  Baseline and Week 10

• Change From Baseline in Acne Severity at Week 10

  The Leeds scale is a 12-point ordinal photonumeric global acne severity scale where a rating of 1 denotes the mildest acne and a rating of 12 represents the most severe.

  Baseline and Week 10

Secondary Outcomes (7)

• Change From Baseline in Papule Acne Lesions at Week 16

  Baseline and Week 16

• Change From Baseline in Pustule Acne Lesions at Week 16

  Baseline and Week 16

• Change From Baseline in Cysts at Week 16

  Baseline and Week 16

• Change From Baseline in Closed Comedones at Week 16

  Baseline and Week 16

• Change From Baseline in Open Comedones at Week 16

  Baseline and Week 16

Study Arms (2)

Laser Therapy

EXPERIMENTAL

V-Beam laser, Candela Corp., 595 nm wavelength

Device: V-Beam laser, Candela Corp., 595 nm wavelength

Control

NO INTERVENTION

Untreated

Interventions

V-Beam laser, Candela Corp., 595 nm wavelength DEVICE

Subjects will receive a series of up to 6 laser therapy sessions with a treatment interval of from approximately 1 to 4 weeks. In all cases, laser treatment parameters will be within the guidelines normally used clinically with the V-Beam laser, and thus fluences used will not exceed 15 J/cm2.

Laser Therapy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 15 years or older of either gender and of any racial/ethnic group.
• Presence of clinically-evident facial acne.
• Subjects must be in generally good health.
• Subjects must be able and willing to comply with the requirements of the protocol.
• You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

You may not qualify if:

• Oral retinoid (Accutane) use within 6 months of entry into the study.
• Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
• Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
• Microdermabrasion or superficial chemical peels at the sites to be treated within 2 months of entry into the study.
• Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
• Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
• Non-compliant subjects.
• Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
• Subjects using alcohol-based topical solutions or "exfoliating" agents within 2 weeks of entry into the study.
• Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
• History of keloid (excessive scar) formation for subjects undergoing biopsies.
• Pregnant or nursing females.
• Subjects with known allergy or hypersensitivity to topical photosensitizing agents.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Dr. Jeffrey Orringer
• Organization: University of Michigan Dept of Dermatology

jorringe@umich.edu

734-936-4075

Study Officials

• John J Voorhees, MD

  University of Michigan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, University of Michigan

Study Record Dates

• First Submitted: June 7, 2005
• First Posted: June 8, 2005
• Study Start: August 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 18, 2016
• Results First Posted: October 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)