Pulsed Dye Laser Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fixed combination of clindamycin 1% + benzoyl peroxide 5%
Pulsed dye laser
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris, laser surgery, pulsed dye lasers, benzoyl peroxidase, clindamycin, randomized controlled trial
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
Sites / Locations
- Laserklinik Karlsruhe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser
Clindamycin 1% + benzoyl peroxide 5%
Arm Description
Outcomes
Primary Outcome Measures
Investigator's Static Global Assessment
Lesions count
Secondary Outcome Measures
Dermatology Life Quality Index
Documentation of side effects
Full Information
NCT ID
NCT01052246
First Posted
January 19, 2010
Last Updated
January 19, 2010
Sponsor
Laserklinik Karlsruhe
1. Study Identification
Unique Protocol Identification Number
NCT01052246
Brief Title
Pulsed Dye Laser Treatment of Acne Vulgaris
Official Title
The Pulsed Dye Laser as an Adjuvant Treatment Modality in Acne Vulgaris - a Randomized Controlled Single Blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laserklinik Karlsruhe
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris, laser surgery, pulsed dye lasers, benzoyl peroxidase, clindamycin, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clindamycin 1% + benzoyl peroxide 5% & pulsed dye laser
Arm Type
Experimental
Arm Title
Clindamycin 1% + benzoyl peroxide 5%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fixed combination of clindamycin 1% + benzoyl peroxide 5%
Intervention Description
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
Device
Intervention Name(s)
Pulsed dye laser
Intervention Description
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
Primary Outcome Measure Information:
Title
Investigator's Static Global Assessment
Time Frame
day 0, day 14, day 28
Title
Lesions count
Time Frame
day 0, day 28
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index
Time Frame
day 0, day 28
Title
Documentation of side effects
Time Frame
day 28
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syrus Karsai, MD
Organizational Affiliation
Laserklinik Karlsruhe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laserklinik Karlsruhe
City
Karlsruhe
ZIP/Postal Code
D-76133
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Pulsed Dye Laser Treatment of Acne Vulgaris
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