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Pulsed Dye Laser Treatment of Acne Vulgaris

NCT01052246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-01-20

No results posted yet for this study

Summary

The results of pulsed dye laser (PDL) treatment of acne vulgaris published so far are controversial: Whereas Seaton et al. described a marked improvement of mild-to-moderate acne after low-fluence pulsed-dye laser therapy, Orringer et al. were unable to replicate said results in a similar, albeit not identical, study design. More recently published studies failed to resolve the controversy, varying in terms of treatment procedure(s) as well as results.

While published results are certainly promising enough to be followed up by independent research, they are insufficient to justify the abdication of methods with proven efficacy. Considering patient treatment ethics and the short 'window of opportunity' for scar prevention when active inflammatory lesions are present, the investigators planned the adjuvant application of the PDL in the present study, providing all patients with the well established and evidentially effective modality of a fixed-combination clindamycin 1%-benzoyl peroxide 5% hydrating gel (C/BPO). The goal of the study was the assessment of the efficacy and safety of a low-fluence PDL treatment in addition to C/BPO in patients with facial inflammatory acne.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Fixed combination of clindamycin 1% + benzoyl peroxide 5%

Topical monotherapy with a fixed combination of 1% clindamycin and 5% benzoyl peroxide hydrating gel (Duac® Akne Gel, Stiefel Laboratorium GmbH, Offenbach, Germany). In order to provide standardized condition within the sample, the gel was applied on the whole face regardless of the lesion location. The gel was applied once per day in the evening throughout the observation period and left in place overnight.

DEVICE

Pulsed dye laser

Patients randomized in the experimental group received two additional treatments with a pulsed dye laser using the following parameters: * Wavelength 585 nm * Energy fluence 3 J/cm2 * Pulse duration 0.35 msec * Spot size 7 mm

Sponsors & Collaborators

  • Laserklinik Karlsruhe

    lead OTHER

Principal Investigators

  • Syrus Karsai, MD · Laserklinik Karlsruhe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-06-30
Completion
2009-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01052246 on ClinicalTrials.gov