- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00113425
Non-cutting Laser Therapy in the Treatment of Acne
Photodynamic Therapy in the Treatment of Acne Vulgaris
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. It is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options.
Recently, the FDA has approved various lasers for the treatment of acne. However, few randomized, controlled clinical trials have been performed. In addition, the use of topical photosensitizers preceding laser therapy for acne has also been examined in a preliminary way with some initial evidence of efficacy. However, these small trials have primarily focused on back acne and have included modest numbers of subjects. Photodynamic therapy for facial acne is being performed by physicians across the country but little objective data regarding this practice is available.
We propose to evaluate the efficacy and confirm the safety of pulsed dye laser therapy (V-Beam laser, Candela Corp., Wayland, MA, 595 nm wavelength) used in conjunction with a topical photosensitizer in the treatment of acne vulgaris. This is a split-face comparison study in which one half of the face will be treated with photo-sensitizer and laser, and the contralateral side will be left untreated. Because one proposed mechanism of action for such treatments includes altered sebaceous gland activity, we also seek to examine the effects of this treatment on cutaneous sebum production.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Laser Therapy
V-Beam laser, Candela Corp., 595 nm wavelength
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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.
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No Intervention: Control
Untreated
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Papule Acne Lesions at Week 10
Time Frame: Baseline and Week 10
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Baseline and Week 10
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Change From Baseline in Pustule Acne Lesions at Week 10
Time Frame: Baseline and Week 10
|
Baseline and Week 10
|
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Change From Baseline in Cysts at Week 10
Time Frame: Baseline and Week 10
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Baseline and Week 10
|
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Change From Baseline in Closed Comedones at Week 10
Time Frame: Baseline and Week 10
|
Baseline and Week 10
|
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Change From Baseline in Open Comedones at Week 10
Time Frame: Baseline and Week 10
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Baseline and Week 10
|
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Change From Baseline in Erythematous Macules at Week 10
Time Frame: Baseline and Week 10
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Baseline and Week 10
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Change From Baseline in Acne Severity at Week 10
Time Frame: Baseline and Week 10
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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.
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Baseline and Week 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Papule Acne Lesions at Week 16
Time Frame: Baseline and Week 16
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Baseline and Week 16
|
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Change From Baseline in Pustule Acne Lesions at Week 16
Time Frame: Baseline and Week 16
|
Baseline and Week 16
|
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Change From Baseline in Cysts at Week 16
Time Frame: Baseline and Week 16
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Baseline and Week 16
|
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Change From Baseline in Closed Comedones at Week 16
Time Frame: Baseline and Week 16
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Baseline and Week 16
|
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Change From Baseline in Open Comedones at Week 16
Time Frame: Baseline and Week 16
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Baseline and Week 16
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Change From Baseline in Erythematous Macules at Week 16
Time Frame: Baseline and Week 16
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Baseline and Week 16
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Change From Baseline in Acne Severity at Week 16
Time Frame: Baseline and Week 16
|
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.
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Baseline and Week 16
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Derm 548
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
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Bispebjerg HospitalCompleted
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Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
Clinical Trials on V-Beam laser, Candela Corp., 595 nm wavelength
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Nick van der BeekAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Active, not recruitingPsoriasis VulgarisNetherlands
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Massachusetts General HospitalShriners Hospitals for ChildrenUnknownBurn ScarsUnited States
-
Henry Ford Health SystemAmerican Academy of Cosmetic SurgeryCompletedPost Surgical ScarsUnited States
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University of ChicagoWithdrawn