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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472900
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):
Nattaporn Rojarayanont, M.D., Chulalongkorn University

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: 2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia) Drug: Benzoyl Peroxide gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Er:YAG laser 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

Active Comparator: BP gel 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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. Patient satisfaction [ Time Frame: week 6 ]
    Self evaluation of patient satisfaction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472900

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Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Additional Information:
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Responsible Party: Nattaporn Rojarayanont, M.D., Faculty of Medicine, Department of Medicine, Dermatological unit, Chulalongkorn University Identifier: NCT01472900    
Other Study ID Numbers: ERYAG-AC01
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012
Keywords provided by Nattaporn Rojarayanont, M.D., Chulalongkorn University:
acne vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents