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Completed

NCT Number: NCT01052246

Pulsed Dye Laser Treatment of Acne Vulgaris

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laserklinik Karlsruhe

Karlsruhe, D-76133, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed combination of clindamycin 1% + benzoyl peroxide 5%

Drug

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.

Pulsed dye laser

Device

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

Primary outcomes

  1. Investigator's Static Global Assessment

    Time frame: day 0, day 14, day 28

  2. Lesions count

    Time frame: day 0, day 28

Secondary outcomes

  1. Dermatology Life Quality Index

    Time frame: day 0, day 28

  2. Documentation of side effects

    Time frame: day 28

Sponsors and collaborators

Lead sponsor

Laserklinik Karlsruhe

Other

Registry information

Official study title

The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 20, 2010
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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