Back to resultsTreatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Primary Purpose
Hypertrophic Scars
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
0.05% Clobetasol propionate
Petrolatum gel
Fractional Erbium:Yag (2,940-nm) laser
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Scars focused on measuring fractional laser, hypertrophic scar, topical corticosteroid, laser assisted delivery systems
Eligibility Criteria
Inclusion Criteria:
- Female subjects with age range 18-60 years;
- Subject with hypertrophic scar from abdominal surgery for at least 3 months;
- Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months
Exclusion Criteria:
- Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
- Subject who smoke cigarette;
- Subject who was treated with Intralesional corticosteroid
Sites / Locations
- Faculty of Medicine Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Laser+Topical corticosteroid
Laser+Petrolatum gel
Arm Description
Hypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side
Hypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side
Outcomes
Primary Outcome Measures
Scar thickness measured by digital calliper
Secondary Outcome Measures
Patient and observer scar assessment scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02487212
Brief Title
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Official Title
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.
Detailed Description
Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.
Recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scars
Keywords
fractional laser, hypertrophic scar, topical corticosteroid, laser assisted delivery systems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser+Topical corticosteroid
Arm Type
Active Comparator
Arm Description
Hypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side
Arm Title
Laser+Petrolatum gel
Arm Type
Placebo Comparator
Arm Description
Hypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side
Intervention Type
Drug
Intervention Name(s)
0.05% Clobetasol propionate
Intervention Description
0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions
Intervention Type
Drug
Intervention Name(s)
Petrolatum gel
Intervention Description
Petrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions
Intervention Type
Device
Intervention Name(s)
Fractional Erbium:Yag (2,940-nm) laser
Intervention Description
The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions
Primary Outcome Measure Information:
Title
Scar thickness measured by digital calliper
Time Frame
change from baseline in scar thickness at 6 months
Secondary Outcome Measure Information:
Title
Patient and observer scar assessment scale
Time Frame
Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female subjects with age range 18-60 years;
Subject with hypertrophic scar from abdominal surgery for at least 3 months;
Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months
Exclusion Criteria:
Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;
Subject who smoke cigarette;
Subject who was treated with Intralesional corticosteroid
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
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