Striae RubraNCT05598190
A577-nm Pro -Yellow Laser In Treatment of Striae Rubra
A study testing Pro-Yellow laser 577 in people with Striae Rubra, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Striae Rubra
- What is being tested?
- Pro-Yellow laser 577
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- .Patients diagnosed with striae rubera. .Age groups: at any age. .Sex : ( females).
- Co-operative patient
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Refaat R Hammed, professor contact
Egypt1 site, 1 recruiting
- Recruiting
AZHAR University Hospital
Asyut
mostafa A Shataat, professor
About this study
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
- Conditions
- Striae Rubra
- Being tested
- Pro-Yellow laser 577
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-Yellow laser 577Device
4 session for cases with digtal photo before and after sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
dermoscopic change of width of striae rubrae
dermoscopic photo for width of striae
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start15 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Striae RubraStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soha Alaa Abdelaal, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598190
- Sponsor's protocol ID
- AZ.AST./DVA021/12/211/9/2022
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25276274Kapicioglu 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.
PubMed 30097757Mohamed 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.
PubMed 31033204Temiz 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.
PubMed 33314488
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A577-nm Pro -Yellow Laser In Treatment of Striae Rubra
- ClinicalTrials.gov ID
- NCT05598190
- Acronym / sponsor ID
- AZ.AST./DVA021/12/211/9/2022
- Conditions
- Striae Rubra
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- .Patients diagnosed with striae rubera. .Age groups: at any age. .Sex : ( females).
Key exclusion criteria (6 listed)
- Pregnancy .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-Yellow laser 5774 session for cases with digtal photo before and after sessions | Device | – |
Primary outcome
dermoscopic change of width of striae rubrae
Time frame: 1 year
dermoscopic photo for width of striae
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Background: PubMed 25276274Dover 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.
- Background: PubMed 30097757Kapicioglu 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.
- Background: PubMed 31033204Mohamed 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.
- Background: PubMed 33314488Temiz 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.
- Individual participant dataSharing planned: Undecided
Related trials for Striae Rubra
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Refaat R Hammed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro-Yellow laser 577 in people with Striae Rubra, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact soha A abdelal, resident doctor (01008189033, sohaalaa.2244@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dermoscopic change of width of striae rubrae (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598190, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.