Pulsed Dye Laser Treatment of Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT01052246|
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : January 20, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5% Device: Pulsed dye laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||September 2009|
|Experimental: Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser||
Device: Pulsed dye laser
Patients randomized in the experimental group received two additional treatments with a pulsed dye laser using the following parameters:
|Active Comparator: Clindamycin 1% + benzoyl peroxide 5%||
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.
- Investigator's Static Global Assessment [ Time Frame: day 0, day 14, day 28 ]
- Lesions count [ Time Frame: day 0, day 28 ]
- Dermatology Life Quality Index [ Time Frame: day 0, day 28 ]
- Documentation of side effects [ Time Frame: day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052246
|Karlsruhe, Germany, D-76133|
|Principal Investigator:||Syrus Karsai, MD||Laserklinik Karlsruhe|