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

Striae Alba Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456257
• Other study ID #: Si 591/2561
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2020
• Source: Mahidol University
• Contact: Woraphong Manuskiatti, M.D.
• Phone: +66819150555
• Email: doctorlaser[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Striae Alba
• Striae Distensae

Intervention

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.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in striae roughness by Antera 3D image		change from baseline in striae roughness score at 6 months
Primary	Change in average Melanin index by Antera 3D image		change from baseline in average melanin index at 6 months
Primary	Change in melanin variation index by Antera 3D image		change from baseline in melanin variation index at 6 months
Secondary	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
Secondary	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