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Pulsed Dye Laser Treatment of Acne Vulgaris

This study has been completed.
Sponsor:
Information provided by:
Laserklinik Karlsruhe
ClinicalTrials.gov Identifier:
NCT01052246
First received: January 19, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention
Acne Vulgaris
 Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5%
Device: Pulsed dye laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Laserklinik Karlsruhe:

Primary Outcome Measures:
  • Investigator's Static Global Assessment [ Time Frame: day 0, day 14, day 28 ] [ Designated as safety issue: No ]
  • Lesions count [ Time Frame: day 0, day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dermatology Life Quality Index [ Time Frame: day 0, day 28 ] [ Designated as safety issue: No ]
  • Documentation of side effects [ Time Frame: day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: October 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  • Wavelength 585 nm
  • Energy fluence 3 J/cm2
  • Pulse duration 0.35 msec
  • Spot size 7 mm
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents and adults with moderate inflammatory acne vulgaris (ISGA degrees 2-4)
  • Fitzpatrick skin type I-III

Exclusion Criteria:

  • Atopic dermatitis
  • Oral antibiotics during the last 4 weeks prior to enrolment
  • Oral isotretinoin during the last 52 weeks prior to enrolment
  • Oral contraceptives during the last 26 weeks prior to enrolment
  • Topical acne therapeutics during the last 4 weeks prior to enrolment
  • Diagnosis or anamnestic indication of a regional enteritis, Morbus Crohn or antibiotics-associated colitis
  • Laser surgery interventions within the treatment region during the last 12 weeks prior to enrolment
  • Coagulation anomalies or anticoagulant treatment
  • Photo-sensitizing medication (e. g., tetracycline, gold)
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052246

Locations
Germany
Laserklinik Karlsruhe
Karlsruhe, Germany, D-76133
Sponsors and Collaborators
Laserklinik Karlsruhe
Investigators
Principal Investigator: Syrus Karsai, MD Laserklinik Karlsruhe
  More Information

No publications provided

Responsible Party: Syrus Karsai/Principal investigator, Laserklinik Karlsruhe
ClinicalTrials.gov Identifier: NCT01052246     History of Changes
Other Study ID Numbers: LK_08_2009
Study First Received: January 19, 2010
Last Updated: January 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Laserklinik Karlsruhe:
acne vulgaris
laser surgery
pulsed dye lasers
 benzoyl peroxidase
clindamycin
randomized controlled trial

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Clindamycin-2-phosphate
 Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 21, 2013