Back to resultsThe Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
Primary Purpose
Striae Alba
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
fractional picosecond 1,064 nm laser
Sponsored by
About this trial
This is an interventional treatment trial for Striae Alba focused on measuring striae alba, fractional picosecond laser, stretch marks
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Siriraj hospital, Mahidol UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fractional Picosecond 1,064 nm laser
Arm Description
The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser
Outcomes
Primary Outcome Measures
Change in striae roughness by Antera 3D image
Change in average Melanin index by Antera 3D image
Change in melanin variation index by Antera 3D image
Secondary Outcome Measures
Investigator assessment scores
Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04456257
Brief Title
The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
Official Title
The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Alba
Keywords
striae alba, fractional picosecond laser, stretch marks
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fractional Picosecond 1,064 nm laser
Arm Type
Experimental
Arm Description
The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser
Intervention Type
Device
Intervention Name(s)
fractional picosecond 1,064 nm laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in striae roughness by Antera 3D image
Time Frame
change from baseline in striae roughness score at 6 months
Title
Change in average Melanin index by Antera 3D image
Time Frame
change from baseline in average melanin index at 6 months
Title
Change in melanin variation index by Antera 3D image
Time Frame
change from baseline in melanin variation index at 6 months
Secondary Outcome Measure Information:
Title
Investigator assessment scores
Description
Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.
Time Frame
Baseline, 1, 3 and 6 months after final treatment
Title
Patient satisfaction scores
Description
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
Time Frame
Baseline, 1, 3, and 6 months after final treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Woraphong Manuskiatti, M.D.
Phone
+66819150555
Email
doctorlaser@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arisa Kaewkes, M.D.
Phone
+66895710956
Email
searisa@yahoo.com
Facility Information:
Facility Name
Faculty of Medicine, Siriraj hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woraphong Manuskiatti, M.D.
Phone
+6624199922
Email
doctorlaser@gmail.com
First Name & Middle Initial & Last Name & Degree
Arisa Kaewkes, M.D.
Phone
+66895710956
Email
searisa@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
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