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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nattaporn Rojarayanont, M.D., Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01472900
First received: November 12, 2011
Last updated: June 17, 2012
Last verified: June 2012
  Purpose

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 Intervention
Acne Vulgaris
Device: 2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)
Drug: Benzoyl Peroxide gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    % change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline


Secondary Outcome Measures:
  • Safety [ Time Frame: week0,2,4 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Self evaluation of patient satisfaction


Estimated Enrollment: 25
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472900

Locations
Thailand
Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
  More Information

Additional Information:
No publications provided

Responsible Party: Nattaporn Rojarayanont, M.D., Faculty of Medicine, Department of Medicine, Dermatological unit, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01472900     History of Changes
Other Study ID Numbers: ERYAG-AC01
Study First Received: November 12, 2011
Last Updated: June 17, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014