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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04456257
Enrollment
12
Registered
2020-07-02
Start date
2020-05-01
Completion date
2020-12-30
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Striae Alba

Keywords

striae alba, fractional picosecond laser, stretch marks

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.

Interventions

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.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Change in striae roughness by Antera 3D imagechange from baseline in striae roughness score at 6 months
Change in average Melanin index by Antera 3D imagechange from baseline in average melanin index at 6 months
Change in melanin variation index by Antera 3D imagechange from baseline in melanin variation index at 6 months

Secondary

MeasureTime frameDescription
Investigator assessment scoresBaseline, 1, 3 and 6 months after final treatmentClinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.
Patient satisfaction scoresBaseline, 1, 3, and 6 months after final treatmentpatient 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

Countries

Thailand

Contacts

Primary ContactWoraphong Manuskiatti, M.D.
doctorlaser@gmail.com+66819150555
Backup ContactArisa Kaewkes, M.D.
searisa@yahoo.com+66895710956

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026