Phase 2 N=44 Randomized Single-blind Treatment

Non-cutting Laser Therapy in the Treatment of Acne

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT00113425 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2016

Primary outcome: Primary: Change From Baseline in Papule Acne Lesions at Week 10 — -4.63; -0.13 papule acne lesions — p=0.01

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: V-Beam laser, Candela Corp., 595 nm wavelength (Device)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Papule Acne Lesions at Week 10	-4.63; -0.13	0.01 sig
PRIMARY Change From Baseline in Pustule Acne Lesions at Week 10	-1.80; -1.20	0.43
PRIMARY Change From Baseline in Cysts at Week 10	0.10; 0.07	0.79
PRIMARY Change From Baseline in Closed Comedones at Week 10	-5.07; -1.17	0.10
PRIMARY Change From Baseline in Open Comedones at Week 10	-1.00; -0.63	0.73
PRIMARY Change From Baseline in Erythematous Macules at Week 10	-1.88; 1.28	0.02 sig
PRIMARY Change From Baseline in Acne Severity at Week 10	-0.90; -0.30	0.003 sig
SECONDARY Change From Baseline in Papule Acne Lesions at Week 16	-1.79; -0.97	0.62
SECONDARY Change From Baseline in Pustule Acne Lesions at Week 16	-2.72; -2.62	0.85
SECONDARY Change From Baseline in Cysts at Week 16	0.38; 0.24	0.49
SECONDARY Change From Baseline in Closed Comedones at Week 16	-6.97; -4.07	0.21
SECONDARY Change From Baseline in Open Comedones at Week 16	-4.79; -6.79	0.27
SECONDARY Change From Baseline in Erythematous Macules at Week 16	-5.89; -2.50	0.04 sig
SECONDARY Change From Baseline in Acne Severity at Week 16	-1.07; -0.52	0.01 sig

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00113425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.