2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne
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
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 12, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 19, 2012
June 1, 2012
1.5 years
November 12, 2011
June 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment
% change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline
6 week
Secondary Outcomes (3)
Safety
week0,2,4
Photographic clinical improvement
week 2,4,6 and 10
Patient satisfaction
week 6
Study Arms (2)
Er:YAG laser
EXPERIMENTALBP gel
ACTIVE COMPARATORInterventions
2 passes of 2940nm Er:YAG laser
2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Chulalongkorn University
Bangkok, 10330, Thailand
Related 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty of Medicine, Department of Medicine, Dermatological unit
Study Record Dates
First Submitted
November 12, 2011
First Posted
November 17, 2011
Study Start
October 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
June 19, 2012
Record last verified: 2012-06