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

Not Applicable

• Conditions: Striae Alba
• Interventions: Device: fractional picosecond 1,064 nm laser

• Registration Number: NCT04456257
• Lead Sponsor: Mahidol University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-26
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fractional Picosecond 1,064 nm laser	fractional picosecond 1,064 nm laser	The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Investigator assessment scores	Baseline, 1, 3 and 6 months after final treatment	Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.
Patient satisfaction scores	Baseline, 1, 3, and 6 months after final treatment	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

Trial Locations

Locations (1)

Faculty of Medicine, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand