A577-nm Pro -Yellow Laser In Treatment of Striae Rubra
Primary Purpose
Striae Rubra
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pro-Yellow laser 577
Sponsored by
About this trial
This is an interventional treatment trial for Striae Rubra
Eligibility Criteria
Inclusion Criteria:
.Patients diagnosed with striae rubera. .Age groups: at any age. .Sex : ( females).
- Co-operative patient
Exclusion Criteria:
Pregnancy .
- Patient using drugs exacerbating stria as topical or systemic steroid, and patients using other forms of treatment for stria as topical tretinoin, emollients, glycolic acid peel and laser, because that might affect the result of our study.
- Stria Alba.
- Skin infection (viral, bacterial or parasitic).
- Immunosuppressed patients or with history of malignancy or radiation therapy and chronic debilitating diseases and Cushing syndrome.
- Hypersensitivity to light and intak of photosensitizing drugs.
Sites / Locations
- AZHAR University HospitalRecruiting
Outcomes
Primary Outcome Measures
dermoscopic change of width of striae rubrae
dermoscopic photo for width of striae
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05598190
Brief Title
A577-nm Pro -Yellow Laser In Treatment of Striae Rubra
Official Title
A577-nm Pro -Yellow Laser In Treatment of Striae Rubra
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stretch marks or striae are common skin condition occurring in both genders, but they are more prevalent among women. These are linear dermal scars that are accompanied by epidermal atrophy. They usually occur frequently in numerous physiological and pathological conditions, such as adolescent growth, pregnancy, obesity, Cushing disease, Marfan syndrome, and long-term systemic or topical steroid use. Decreased expression of collagen and fibronectin genes has also been associated with striae.
The pro-yellow laser systems can be used in a wide range of indications such as facial erythema, facial telangiectasia, port wine stain nevus, rosacea, poikilo derma civatte, and Becker's nevus
Some of these indications are clinical lesions in the vascular pattern; some are related to the factors that trigger vascularity, such as vascular endothelial growth factor (VEGF) in etiopathogenesis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Rubra
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pro-Yellow laser 577
Intervention Description
4 session for cases with digtal photo before and after sessions
Primary Outcome Measure Information:
Title
dermoscopic change of width of striae rubrae
Description
dermoscopic photo for width of striae
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
.Patients diagnosed with striae rubera. .Age groups: at any age. .Sex : ( females).
Co-operative patient
Exclusion Criteria:
Pregnancy .
Patient using drugs exacerbating stria as topical or systemic steroid, and patients using other forms of treatment for stria as topical tretinoin, emollients, glycolic acid peel and laser, because that might affect the result of our study.
Stria Alba.
Skin infection (viral, bacterial or parasitic).
Immunosuppressed patients or with history of malignancy or radiation therapy and chronic debilitating diseases and Cushing syndrome.
Hypersensitivity to light and intak of photosensitizing drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
soha A abdelal, resident doctor
Phone
01008189033
Email
sohaalaa.2244@azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Refaat R Hammed, professor
Facility Information:
Facility Name
AZHAR University Hospital
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mostafa A Shataat, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25276274
Citation
Dover JS, Rothaus K, Gold MH. Evaluation of safety and patient subjective efficacy of using radiofrequency and pulsed magnetic fields for the treatment of striae (stretch marks). J Clin Aesthet Dermatol. 2014 Sep;7(9):30-3.
Results Reference
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PubMed Identifier
30097757
Citation
Kapicioglu Y, Sarac G, Cenk H. Treatment of erythematotelangiectatic rosacea, facial erythema, and facial telangiectasia with a 577-nm pro-yellow laser: a case series. Lasers Med Sci. 2019 Feb;34(1):93-98. doi: 10.1007/s10103-018-2606-6. Epub 2018 Aug 10.
Results Reference
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PubMed Identifier
31033204
Citation
Mohamed EM, Mohamed Tawfik K, Hassan Ahmad W. Successful treatment of facial vascular skin diseases with a 577-nm pro-yellow laser. J Cosmet Dermatol. 2019 Dec;18(6):1675-1679. doi: 10.1111/jocd.12963. Epub 2019 Apr 29.
Results Reference
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PubMed Identifier
33314488
Citation
Temiz SA, Arazov S, Ataseven A, Dursun R. Treatment of Becker's nevus with 577-nm pro-yellow laser: Could it be a new treatment choice? J Cosmet Dermatol. 2021 Feb;20(2):705-706. doi: 10.1111/jocd.13882. Epub 2020 Dec 14. No abstract available.
Results Reference
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Learn more about this trial
A577-nm Pro -Yellow Laser In Treatment of Striae Rubra
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