- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01472900
2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne
June 17, 2012 updated by: Nattaporn Rojarayanont, M.D., Chulalongkorn University
A Randomized Split-Face Controlled Trial Comparing Efficacy of 2940 Nanometer Er:YAG Laser to 2.5% BP Gel for the Treatment of Inflammatory Acne
Acne is one of the most common conditions that patients seek for help in dermatological clinic.
Nowadays, conventional treatment including topical agents(retinoids, antibiotics ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a satisfying result but not to every patient.
Some patients are not well respond to conventional therapy while some patients are unable to tolerate side effects of the treatments.
Therefore, interventions to reduce acne are vigorously experimented .
Lights and lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and infrared lasers have been found to be useful in treating active inflammatory acne.
Although,pain ,downtime and poor response of comedonal acne are limitations of those lights and lasers therapy.
2940 nm Erbium:YAG laser which has both resurfacing and photothermal effects is our laser of interest to seek for its efficacy in the treatment of inflammatory acne.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10330
- Faculty of Medicine, Chulalongkorn University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 year-old to 45 year-old
- Mild to moderate severity of acne vulgaris with at least 5 active inflammatory acne lesions on each side of the face and less than 25% difference in lesion count between each side of face
- Fitzpatrick skin phototype I-IV
Exclusion Criteria:
- History or clinical presentation of hypertrophic scar or keloid
- Photoaggravated skin diseases i.e. systemic lupus erythematosus, polymorphous light eruption, solar urticaria
- Oral isotretinoin taken within the last 6 months prior to enrollment
- Topical retinoid within 4 weeks prior to enrollment
- Systemic acne therapies (oral antibiotics) within 4 week prior to enrollment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Er:YAG laser
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2 passes of 2940nm Er:YAG laser
Other Names:
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Active Comparator: BP gel
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2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment
Time Frame: 6 week
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% change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline
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6 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: week0,2,4
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Safety profile of 2940nm Er:YAG laser for the treatment of inflammatory acne including;
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week0,2,4
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Photographic clinical improvement
Time Frame: week 2,4,6 and 10
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Photographic clinical improvement of acne, acne scar, erythema, hyperpigmentation and overall improvement by blinded dermatologists using quartile grading system comparing baseline and each clinical visit (week 2,4,6 and 10)
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week 2,4,6 and 10
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Patient satisfaction
Time Frame: week 6
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Self evaluation of patient satisfaction
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week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
- Management of acne: a report from a Global Alliance to Improve Outcomes in Acne
- Persistent acne in women : implications for the patient and for therapy
- The quality of life in acne: a comparison with general medical conditions using generic questionnaires
- New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group
- Prevalence and severity of facial and truncal acne in a referral cohort
- Profile of acne vulgaris--a hospital-based study from South India
- Guidelines of care for acne vulgaris management
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
November 12, 2011
First Submitted That Met QC Criteria
November 16, 2011
First Posted (Estimate)
November 17, 2011
Study Record Updates
Last Update Posted (Estimate)
June 19, 2012
Last Update Submitted That Met QC Criteria
June 17, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERYAG-AC01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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