Acne Vulgaris
Conditions
Keywords
acne vulgaris, laser surgery, pulsed dye lasers, benzoyl peroxidase, clindamycin, randomized controlled trial
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.
Interventions
DRUGFixed 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.
DEVICEPulsed 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
Sponsors
Laserklinik Karlsruhe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator's Static Global Assessment | day 0, day 14, day 28 |
| Lesions count | day 0, day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index | day 0, day 28 |
| Documentation of side effects | day 28 |
Countries
Germany
Outcome results
None listed