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

NCT ID: NCT04456257

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Striae Alba

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fractional Picosecond 1,064 nm laser

The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser

Group Type EXPERIMENTAL

fractional picosecond 1,064 nm laser

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Woraphong Manuskiatti, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Siriraj hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Woraphong Manuskiatti, M.D.

Role: CONTACT

+66819150555

Arisa Kaewkes, M.D.

Role: CONTACT

+66895710956

Facility Contacts

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Woraphong Manuskiatti, M.D.

Role: primary

+6624199922

Arisa Kaewkes, M.D.

Role: backup

+66895710956

Other Identifiers

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Si 591/2561

Identifier Type: -

Identifier Source: org_study_id

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