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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472900
• Other study ID #: ERYAG-AC01
• Status: Completed
• Phase: N/A
• First received: November 12, 2011
• Last updated: June 17, 2012
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Drug:
• Benzoyl Peroxide gel
2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety	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.	week0,2,4	Yes
Secondary	Photographic clinical improvement	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)	week 2,4,6 and 10	No
Secondary	Patient satisfaction	Self evaluation of patient satisfaction	week 6	No

External Links

•   Guidelines of care for acne vulgaris management
•   Management of acne: a report from a Global Alliance to Improve Outcomes in Acne
•   New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group
•   Persistent acne in women : implications for the patient and for therapy
•   Prevalence and severity of facial and truncal acne in a referral cohort
•   Profile of acne vulgaris--a hospital-based study from South India
•   The quality of life in acne: a comparison with general medical conditions using generic questionnaires