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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)
Benzoyl Peroxide gel
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Er:YAG laser

BP gel

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)
Patient satisfaction
Self evaluation of patient satisfaction

Full Information

First Posted
November 12, 2011
Last Updated
June 17, 2012
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01472900
Brief Title
2940nm Er:YAG Laser Versus Benzoyl Peroxide Gel for the Treatment of Inflammatory Acne
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Er:YAG laser
Arm Type
Experimental
Arm Title
BP gel
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)
Other Intervention Name(s)
DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia
Intervention Description
2 passes of 2940nm Er:YAG laser
Intervention Type
Drug
Intervention Name(s)
Benzoyl Peroxide gel
Other Intervention Name(s)
2.5% benzoyl peroxide gel
Intervention Description
2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face
Primary Outcome Measure Information:
Title
percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment
Description
% change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
week0,2,4
Title
Photographic clinical improvement
Description
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)
Time Frame
week 2,4,6 and 10
Title
Patient satisfaction
Description
Self evaluation of patient satisfaction
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/12833004
Description
Management of acne: a report from a Global Alliance to Improve Outcomes in Acne
URL
http://www.ncbi.nlm.nih.gov/pubmed/17007539
Description
Persistent acne in women : implications for the patient and for therapy
URL
http://www.ncbi.nlm.nih.gov/pubmed/10233319
Description
The quality of life in acne: a comparison with general medical conditions using generic questionnaires
URL
http://www.ncbi.nlm.nih.gov/pubmed/19376456
Description
New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group
URL
http://www.ncbi.nlm.nih.gov/pubmed/18561586
Description
Prevalence and severity of facial and truncal acne in a referral cohort
URL
http://www.ncbi.nlm.nih.gov/pubmed/19439880
Description
Profile of acne vulgaris--a hospital-based study from South India
URL
http://www.ncbi.nlm.nih.gov/pubmed/17276540
Description
Guidelines of care for acne vulgaris management

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

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