Pulsed Dye Laser Treatment of Acne Vulgaris

Laserklinik Karlsruhe

Status: Completed

Conditions: Acne Vulgaris

Treatments: Device: Pulsed dye laser; Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT01052246

LK_08_2009

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

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

Experimental group

Treatment:

Device: Pulsed dye laser

Clindamycin 1% + benzoyl peroxide 5%

Active Comparator group

Treatment:

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