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

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.

Study Overview

• Status: Unknown
• Conditions: Striae Alba
• Intervention / Treatment: Device: fractional picosecond 1,064 nm laser

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Woraphong Manuskiatti, M.D.; Phone Number: +66819150555; Email: doctorlaser@gmail.com
• Study Contact Backup: Name: Arisa Kaewkes, M.D.; Phone Number: +66895710956; Email: searisa@yahoo.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Recruiting
      • Faculty of medicine, Siriraj hospital, Mahidol university
      • Contact: Arisa Kaewkes, M.D.; Phone Number: +66895710956; Email: searisa@yahoo.com
      • Contact: Woraphong Manuskiatti, M.D.; Phone Number: +6624199922; Email: doctorlaser@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fractional Picosecond 1,064 nm laser; The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser	Device: fractional picosecond 1,064 nm laser; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (ACTUAL): July 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: striae alba, fractional picosecond laser, stretch marks
• Additional Relevant MeSH Terms: Skin Manifestations; Striae Distensae
• Other Study ID Numbers: Si 591/2561

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No