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Completed

NCT Number: NCT01472900

2940nm Er:YAG Laser Versus Benzoyl Peroxide 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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)

Device

2 passes of 2940nm Er:YAG laser

Other names: DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia

Benzoyl Peroxide gel

Drug

2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face

Other names: 2.5% benzoyl peroxide gel

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 17, 2011
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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