The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
Overview
- Phase
- Not Applicable
- Sponsor
- Mahidol University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in striae roughness by Antera 3D image
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in striae roughness by Antera 3D image
Time Frame: change from baseline in striae roughness score at 6 months
Change in average Melanin index by Antera 3D image
Time Frame: change from baseline in average melanin index at 6 months
Change in melanin variation index by Antera 3D image
Time Frame: change from baseline in melanin variation index at 6 months
Secondary Outcomes
- Investigator assessment scores(Baseline, 1, 3 and 6 months after final treatment)
- Patient satisfaction scores(Baseline, 1, 3, and 6 months after final treatment)
Investigators
Woraphong Manuskiatti, M.D.
Professor
Mahidol University