Striae DistensaeNCT07001644
Microneedling Versus Carboxytherapy in Stria Distensae Rubra
A study testing microneedling and Carboxytherapy in people with Striae Distensae, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare the efficacy and safety of microneedling and carboxytherapy either with or without platelet-rich plasma in the treatment of striae distensae rubra. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Striae Distensae
- What is being tested?
- microneedling and Carboxytherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to Dec 2025
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients.
- Age ranging from 18-45 years old.
- Fitzpatrick skin type III-IV.
- Striae distensae rubra on the abdomen (bilateral and more or less symmetrical).
Who cannot join
- Patients taking immunosuppressants or having any disease affecting wound healing including diabetes.
- Patients receiving systemic glucocorticoids for chronic health conditions.
- Patients with chronic dermatologic diseases such as psoriasis and vitiligo.
- Pregnant and lactating females.
- Patients with a tendency for keloid formation.
- Patients with endocrine disturbance.
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- Patients with autoimmune diseases, systemic diseases such as severe anemia, respiratory, cardiac, renal or liver disorder.
- Patients with bleeding and coagulation disorders.
- Patients who received any form of treatment for their SD in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microneedling Versus Carboxytherapy Either With or Without Platelet Rich Plasma in Treating Stria Distensae Rubra
The aim of this study is to evaluate and compare the efficacy and safety of microneedling and carboxytherapy either with or without platelet-rich plasma in the treatment of striae distensae rubra.
- Conditions
- Striae Distensae
- Being tested
- microneedling, Carboxytherapy
- Keywords
- striae distensae, striae rubra, microneedling, carboxytherapy
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedlingDevice
microneedling with topical application of PRP on one side of abdomen and microneedling only on the other side.
CarboxytherapyDevice
carboxytherapy with intradermal injection of PRP on one side of abdomen and carboxytherapy only on the other side.
| Study group | Role | What they receive |
|---|---|---|
| treated with microneedling | Active comparator | microneedling with topical application of PRP on one side of abdomen and microneedling only on the other side Receives: Device: microneedling |
| treated with carboxytherapy | Active comparator | carboxytherapy with intradermal injection of PRP on one side of abdomen and carboxytherapy only on the other side Receives: Device: Carboxytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the size of the stria distensae rubra
will be assessed by digital photography, actual measurement of the stria before and after treatment, and objective assessment of the percent of improvement
Measured: group I: six sessions over 18 weeks , group II: 6 sessions over 12 weeks, followed in both groups by three months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Oct 2022
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- professor doctor Amira Eid, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001644
- Sponsor's protocol ID
- 0107162
- Status last verified
- Oct 2024
- First submitted
- 17 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedling Versus Carboxytherapy Either With or Without Platelet Rich Plasma in Treating Stria Distensae Rubra
- ClinicalTrials.gov ID
- NCT07001644
- Acronym / sponsor ID
- 0107162
- Conditions
- Striae Distensae
- Keywords
- striae distensae, striae rubra, microneedling, carboxytherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Jun 2025 (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.
The aim of this study is to evaluate and compare the efficacy and safety of microneedling and carboxytherapy either with or without platelet-rich plasma in the treatment of striae distensae rubra.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated with microneedling | Active comparator | Device: microneedlingmicroneedling with topical application of PRP on one side of abdomen and microneedling only on the other side |
| treated with carboxytherapy | Active comparator | Device: Carboxytherapycarboxytherapy with intradermal injection of PRP on one side of abdomen and carboxytherapy only on the other side |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients.
- Age ranging from 18-45 years old.
- Fitzpatrick skin type III-IV.
- Striae distensae rubra on the abdomen (bilateral and more or less symmetrical).
Key exclusion criteria (9 listed)
- Patients taking immunosuppressants or having any disease affecting wound healing including diabetes.
- Patients receiving systemic glucocorticoids for chronic health conditions.
- Patients with chronic dermatologic diseases such as psoriasis and vitiligo.
- Pregnant and lactating females.
- Patients with a tendency for keloid formation.
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 |
|---|---|---|
| microneedlingmicroneedling with topical application of PRP on one side of abdomen and microneedling only on the other side. | Device | treated with microneedling |
| Carboxytherapycarboxytherapy with intradermal injection of PRP on one side of abdomen and carboxytherapy only on the other side. | Device | treated with carboxytherapy |
Primary outcome
Reduction in the size of the stria distensae rubra
Time frame: group I: six sessions over 18 weeks , group II: 6 sessions over 12 weeks, followed in both groups by three months of follow up
will be assessed by digital photography, actual measurement of the stria before and after treatment, and objective assessment of the percent of improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
professor doctor Amira Eid principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microneedling and Carboxytherapy in people with Striae Distensae, run by Alexandria 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 4 inclusion and 9 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 17 Jun 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the size of the stria distensae rubra (time frame: group I: six sessions over 18 weeks , group II: 6 sessions over 12 weeks, followed in both groups by three months of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2025.