Pulsed Dye Laser Treatment of Acne Vulgaris

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Device: Pulsed dye laser; Drug: Fixed combination of clindamycin 1% + benzoyl peroxide 5%

• Registration Number: NCT01052246
• Lead Sponsor: Laserklinik Karlsruhe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Last Update Submitted: 2010-01-19
• Study First Posted: 2010-01-20
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser	Pulsed dye laser	-
Clindamycin 1% + benzoyl peroxide 5%	Fixed combination of clindamycin 1% + benzoyl peroxide 5%	-

Primary Outcome Measures

Name	Time	Method
Investigator's Static Global Assessment	day 0, day 14, day 28
Lesions count	day 0, day 28

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index	day 0, day 28
Documentation of side effects	day 28

Trial Locations

Locations (1)

Laserklinik Karlsruhe; 🇩🇪 Karlsruhe, Germany