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2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne

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ClinicalTrials.gov Identifier: NCT01472900
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Nattaporn Rojarayanont, M.D., Chulalongkorn University

Tracking Information
First Submitted Date  ICMJE November 12, 2011
First Posted Date  ICMJE November 17, 2011
Last Update Posted Date June 19, 2012
Study Start Date  ICMJE October 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment [ Time Frame: 6 week ]
% change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01472900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
  • Safety [ Time Frame: week0,2,4 ]
    Safety profile of 2940nm Er:YAG laser for the treatment of inflammatory acne including;
    • Visual analogue scale of pain score
    • Adverse events(AEs) include types of AEs(erythema, pain/burning sensation, dryness/excessive scaling, pigmentary change), timing, intenstity, outcome and action taking regarding to study procedure particular subject.
  • Photographic clinical improvement [ Time Frame: week 2,4,6 and 10 ]
    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)
  • Patient satisfaction [ Time Frame: week 6 ]
    Self evaluation of patient satisfaction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Device: 2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)
    2 passes of 2940nm Er:YAG laser
    Other Name: DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia
  • Drug: Benzoyl Peroxide gel
    2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face
    Other Name: 2.5% benzoyl peroxide gel
Study Arms  ICMJE
  • Experimental: Er:YAG laser
    Intervention: Device: 2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)
  • Active Comparator: BP gel
    Intervention: Drug: Benzoyl Peroxide gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 16, 2011)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01472900
Other Study ID Numbers  ICMJE ERYAG-AC01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nattaporn Rojarayanont, M.D., Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chulalongkorn University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP