Pulsed Dye Laser Treatment of Acne Vulgaris

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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Device: Pulsed dye laser; Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5%

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Karlsruhe, Germany, D-76133
    • Laserklinik Karlsruhe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigator's Static Global Assessment	day 0, day 14, day 28
Lesions count	day 0, day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Dermatology Life Quality Index	day 0, day 28
Documentation of side effects	day 28

Collaborators and Investigators

• Sponsor: Laserklinik Karlsruhe

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: January 19, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 19, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: randomized controlled trial; clindamycin; acne vulgaris; laser surgery; pulsed dye lasers; benzoyl peroxidase
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
• Other Study ID Numbers: LK_08_2009