Pulsed Dye Laser Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052246
• Other study ID #: LK_08_2009
• Status: Completed
• Phase: N/A
• First received: January 19, 2010
• Last updated: January 19, 2010
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2010
• Source: Laserklinik Karlsruhe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• 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.

Device:
• 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

Locations

Country	Name	City	State
Germany	Laserklinik Karlsruhe	Karlsruhe

Sponsors (1)

Lead Sponsor	Collaborator
Laserklinik Karlsruhe

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Static Global Assessment		day 0, day 14, day 28	No
Primary	Lesions count		day 0, day 28	No
Secondary	Dermatology Life Quality Index		day 0, day 28	No
Secondary	Documentation of side effects		day 28	Yes