Pulsed Dye Laser Treatment of Acne Vulgaris

NCT01052246 | Completed

• 1 other identifier: LK_08_2009
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

acne vulgaris; laser surgery; pulsed dye lasers; benzoyl peroxidase; clindamycin; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Investigator's Static Global Assessment

  day 0, day 14, day 28

• Lesions count

  day 0, day 28

Secondary Outcomes (2)

• Dermatology Life Quality Index

  day 0, day 28

• Documentation of side effects

  day 28

Study Arms (2)

Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser

EXPERIMENTAL

Device: Pulsed dye laser

Clindamycin 1% + benzoyl peroxide 5%

ACTIVE COMPARATOR

Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5%

Interventions

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.

Clindamycin 1% + benzoyl peroxide 5%

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

Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laserklinik Karlsruhe: lead

Study Sites (1)

Laserklinik Karlsruhe

Karlsruhe, D-76133, Germany

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Syrus Karsai, MD

  Laserklinik Karlsruhe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 20, 2010
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

DE (1)