NCT05598190

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

October 25, 2022

Last Update Submit

October 27, 2022

Conditions

Striae Rubra

Outcome Measures

Primary Outcomes (1)

  • dermoscopic change of width of striae rubrae

    dermoscopic photo for width of striae

    1 year

Interventions

Pro-Yellow laser 577DEVICE

4 session for cases with digtal photo before and after sessions

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with striae rubera. .Age groups: at any age. .Sex : ( females).
  • Co-operative patient

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZHAR University Hospital

Asyut, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 25276274BACKGROUND

  • 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.

    PMID: 30097757BACKGROUND

  • 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.

    PMID: 31033204BACKGROUND

  • 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.

    PMID: 33314488BACKGROUND

Central Study Contacts

soha A abdelal, resident doctor

CONTACT

01008189033sohaalaa.2244@azhar.edu.eg

Refaat R Hammed, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor atD dermatology department

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

September 15, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations

EG(1)