Pulsed Dye Laser Treatment of Acne Vulgaris

NCT ID: NCT01052246

Last Updated: 2010-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Pulsed dye laser

Intervention Type: 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%

Group Type: ACTIVE_COMPARATOR

Fixed combination of clindamycin 1% + benzoyl peroxide 5%

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DEVICE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laserklinik Karlsruhe

OTHER

Sponsor Role: lead

Responsible Party

Laserklinik Karlsruhe

Principal Investigators

Syrus Karsai, MD

Role: PRINCIPAL_INVESTIGATOR

Laserklinik Karlsruhe

Locations

Laserklinik Karlsruhe

Karlsruhe, , Germany

Countries

Germany

Other Identifiers

LK_08_2009

Identifier Type: -

Identifier Source: org_study_id