The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.

Detailed Description
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Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. Despite numerous available therapeutic modalities, no gold standard therapy has been established. Picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. The main mechanism of action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.

Official Title
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The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae

Conditions
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Striae Alba

Intervention / Treatment
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* Device: fractional picosecond 1,064 nm laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Striae alba on abdomen for more than 3 months Fitzpatrick skin type III-V Exclusion Criteria: Pregnancy and breastfeeding Previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study History of using Isotretinoin Photosensitive dermatoses, Infection, eczema Past history or family history of malignancy History of herpes infection History of hypertrophic scar or keloid, connective tissue disease History of collagen or elastin disease History of smoking Significant fluctuations in weight in the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional Picosecond 1,064 nm laser<br>The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser | Device: fractional picosecond 1,064 nm laser<br>* The parameter of laser was 8-mm spot size, 0.6 mJ/cm2, 750 ps, 10 Hz, 2 passes. The treatment was done in every 4 weeks for 4 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in striae roughness by Antera 3D image |  | change from baseline in striae roughness score at 6 months | 
| Change in average Melanin index by Antera 3D image |  | change from baseline in average melanin index at 6 months | 
| Change in melanin variation index by Antera 3D image |  | change from baseline in melanin variation index at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment scores | Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators. | Baseline, 1, 3 and 6 months after final treatment | 
| Patient satisfaction scores | patient satisfaction questionnaire was done by grading on a scale of 0 to 4; 0: no improvement, 1: <25% improvement, 2: 25-50% improvement, 3: 51-75% improvement, 4: > 75% improvement | Baseline, 1, 3, and 6 months after final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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striae alba, fractional picosecond laser, stretch marks