StriaePhase 1NCT07154030
Efficacy Of Combined Microneedling Plus Tretinoin In Treatment Of Stria Rubra
A Phase 1 study testing Micro needle injection and Micro needle injection only in people with Striae, run by Sohag University.
Trial summary
Striae distensae (SD), commonly known as stretch marks, are linear dermal scars accompanied by epidermal atrophy . They are often associated with psychological morbidity with a negative impact on quality of life .They are mainly caused by marked stretching in the skin leading to dermal damage and epidermal thinning… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Striae
- What is being tested?
- Micro needle injection and Micro needle injection only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2025to 5 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The study will include patients with stria rubra aged ≥18
Who cannot join
- 1.Pregnant \& lactating patients. 2.Patients with bleeding disorders or on anticoagulant therapy. 3.Patients using drugs that exacerbate the striae as systemic corticosteroids in the preceding two months or topical corticosteroid in the preceding one month.
- 4.Patients having active infection at the treatment area. 5.Patients with keloidal tendency. 6.Patients using other forms of treatment for stria as emollients, glycolic acid peel and laser over the last 2 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Zeinab baha Gouda, lecturer contact
About this study
Official title: Efficacy Of Combined Microneedling Plus Tretinoin 0.025% Or Timolol 0.5% In Treatment Of Stria Rubra
Striae distensae (SD), commonly known as stretch marks, are linear dermal scars accompanied by epidermal atrophy . They are often associated with psychological morbidity with a negative impact on quality of life .They are mainly caused by marked stretching in the skin leading to dermal damage and epidermal thinning, leading to linear atrophic scars .
Stretch marks are more common in women , their prevalence in puberty range from 6% to 86% and in obesity, it is 43%. Striae gravidarum (SG), (stretch marks of pregnancy) range between 50% and 90% ,and are more common in younger women.
Read the detailed description
Striae distensae are most commonly found on the thighs, buttocks, and breasts in girls, and on the lumbosacral area or the outside surface of the thighs in boys. SG appears in the third trimester on the abdomen, breasts or thighs. They are more common in young primigravidae and are linked to higher pregnancy weight, large for gestational age new born, and a higher risk of traumatic vaginal birth .
The SD comes in two forms: striae rubrae (SR) and striae alba (SA). The initial erythematous, stretched flat lesions that are aligned perpendicular to the direction of skin tension represent the acute stage (SR) and they can cause mild itching. The chronic stage (SA) is described when SD have faded and appears atrophic, wrinkled and hypopigmented .
The most common causes of SD include a growth spurt during puberty, pregnancy, positive family history, obesity, and rapid weight gain or loss . Genetic causes including Marfan syndrome, Ehler-Danlos syndrome, and ectodermal dysplasia .
Other causes include cushing disease, anorexia nervosa, infections like T.B and typhoid, chronic liver disease and impaired elastic fibres of dermis. Iatrogenic causes include long term use of topical and systemic steroids and anti-retroviral drugs . Overstretching of the skin lead to dermal damage with inflammatory edema leading to rupture of collagen, elastin and fibronectin. Additionally, there is a defect in fibroblast function, with decrease in fibrillin and elastin production and lack of collagen organization . The treatment modalities for SD range from topical agents to more advanced laser and energy-based devices . Topical treatments such as tretinoin and glycolic acid are widely used for their ability to enhance collagen production and improve skin texture.
Lasers and light devices, particularly fractional CO2 lasers, efficiently promote dermal remodeling and improve the appearance of both SR and SA. No single therapy has emerged as the "gold standard," and combination therapies are recommended . Microneedling as a method of treating stretch marks, stimulates intradermal collagen production , also it can be used as a method of achieving trans-epidermal drug delivery.it also helps elimination of damaged old collagen . Microneedling leads to the release of several growth factors, including platelet-derived growth factors, fibroblast growth factors, and transforming growth factors alpha and beta, which stimulate the migration and proliferation of fibroblasts, producing new collagen and elastin in the papillary dermis. In addition, new capillaries are formed, this neovascularization and neocollagenesis following treatment lead to reduction of scars. The procedure is therefore called "percutaneous collagen induction therapy" .
- Conditions
- Striae
- Being tested
- Micro needle injection, Micro needle injection only
- Keywords
- Timolol, Tretinoin, Stria Rubra, Microneedling
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro needle injectionProcedure or surgery
- Disinfection: the affected area by alcohol 70 %.
- Topical anaesthetic cream will be applied: pridocaine (lidocaine 2.5% and prilocaine 2.5%) for 30 minutes under occlusion.
- Microneedling with tretinoin 0.025% of the affected area will be done by dermapen that will be applied on the affected area as follows: inserting the sterilized needle into the dermapen tip, turning on using speed setting and adjusting speed on 5, needle depth of dermapen will be adjusted to (2- 2.5mm) according to the site of the striae, passing vertically over the striae with dermapen in a stamping pattern until pin point bleeding appear.
Micro needle injection onlyProcedure or surgery
- Disinfection: the affected area by alcohol 70 %.
- Topical anesthetic cream will be applied: pridocaine (lidocaine 2.5% and prilocaine 2.5%) for 30 minutes under occlusion.
- Microneedling with timolol 0.5% of the affected area will be done by derma pen that will be applied on the affected area as follows: inserting the sterilized needle into the derma pen tip, turning on using speed setting and adjusting speed on 5, needle depth of derma pen will be adjusted to (2- 2.5mm) according to the site of the striae, passing vertically over the striae with derma pen in a stamping pattern until pin point bleeding appear.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | microneedling plus tretinoin 0.025% Receives: Procedure: Micro needle injection; Procedure: Micro needle injection only |
| Group 2 | Experimental | microneedling plus timolol 0.5% Receives: Procedure: Micro needle injection; Procedure: Micro needle injection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes
Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start5 Sep 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StriaeStudies of the same condition, open and under way.
- More trials run by Sohag 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Mostafa Hashem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154030
- Sponsor's protocol ID
- Soh-Med-25-7-7MS
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Combined Microneedling Plus Tretinoin 0.025% Or Timolol 0.5% In Treatment Of Stria Rubra
- ClinicalTrials.gov ID
- NCT07154030
- Acronym / sponsor ID
- Soh-Med-25-7-7MS
- Conditions
- Striae
- Keywords
- Timolol, Tretinoin, Stria Rubra, Microneedling
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 5 Sep 2026 (estimated)
- First posted
- 4 Sep 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.
Striae distensae (SD), commonly known as stretch marks, are linear dermal scars accompanied by epidermal atrophy . They are often associated with psychological morbidity with a negative impact on quality of life .They are mainly caused by marked stretching in the skin leading to dermal damage and epidermal thinning, leading to linear atrophic scars .
Stretch marks are more common in women , their prevalence in puberty range from 6% to 86% and in obesity, it is 43%. Striae gravidarum (SG), (stretch marks of pregnancy) range between 50% and 90% ,and are more common in younger women.
Detailed description
Striae distensae are most commonly found on the thighs, buttocks, and breasts in girls, and on the lumbosacral area or the outside surface of the thighs in boys. SG appears in the third trimester on the abdomen, breasts or thighs. They are more common in young primigravidae and are linked to higher pregnancy weight, large for gestational age new born, and a higher risk of traumatic vaginal birth .
The SD comes in two forms: striae rubrae (SR) and striae alba (SA). The initial erythematous, stretched flat lesions that are aligned perpendicular to the direction of skin tension represent the acute stage (SR) and they can cause mild itching. The chronic stage (SA) is described when SD have faded and appears atrophic, wrinkled and hypopigmented .
The most common causes of SD include a growth spurt during puberty, pregnancy, positive family history, obesity, and rapid weight gain or loss . Genetic causes including Marfan syndrome, Ehler-Danlos syndrome, and ectodermal dysplasia .
Other causes include cushing disease, anorexia nervosa, infections like T.B and typhoid, chronic liver disease and impaired elastic fibres of dermis. Iatrogenic causes include long term use of topical and systemic steroids and anti-retroviral drugs . Overstretching of the skin lead to dermal damage with inflammatory edema leading to rupture of collagen, elastin and fibronectin. Additionally, there is a defect in fibroblast function, with decrease in fibrillin and elastin production and lack of collagen organization . The treatment modalities for SD range from topical agents to more advanced laser and energy-based devices . Topical treatments such as tretinoin and glycolic acid are widely used for their ability to enhance collagen production and improve skin texture.
Lasers and light devices, particularly fractional CO2 lasers, efficiently promote dermal remodeling and improve the appearance of both SR and SA. No single therapy has emerged as the "gold standard," and combination therapies are recommended . Microneedling as a method of treating stretch marks, stimulates intradermal collagen production , also it can be used as a method of achieving trans-epidermal drug delivery.it also helps elimination of damaged old collagen . Microneedling leads to the release of several growth factors, including platelet-derived growth factors, fibroblast growth factors, and transforming growth factors alpha and beta, which stimulate the migration and proliferation of fibroblasts, producing new collagen and elastin in the papillary dermis. In addition, new capillaries are formed, this neovascularization and neocollagenesis following treatment lead to reduction of scars. The procedure is therefore called "percutaneous collagen induction therapy" .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Micro needle injection, Procedure: Micro needle injection onlymicroneedling plus tretinoin 0.025% |
| Group 2 | Experimental | Procedure: Micro needle injection, Procedure: Micro needle injection onlymicroneedling plus timolol 0.5% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will include patients with stria rubra aged ≥18
Key exclusion criteria (2 listed)
- 1.Pregnant \& lactating patients. 2.Patients with bleeding disorders or on anticoagulant therapy. 3.Patients using drugs that exacerbate the striae as systemic corticosteroids in the preceding two months or topical corticosteroid in the preceding one month.
- 4.Patients having active infection at the treatment area. 5.Patients with keloidal tendency. 6.Patients using other forms of treatment for stria as emollients, glycolic acid peel and laser over the last 2 months.
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 |
|---|---|---|
| Micro needle injection* Disinfection: the affected area by alcohol 70 %. * Topical anaesthetic cream will be applied: pridocaine (lidocaine 2.5% and prilocaine 2.5%) for 30 minutes under occlusion. * Microneedling with tretinoin 0.025% of the affected area will be done by dermapen that will be applied on the affected area as follows: inserting the sterilized needle into the dermapen tip, turning on using speed setting and adjusting speed on 5, needle depth of dermapen will be adjusted to (2- 2.5mm) according to the site of the striae, passing vertically over the striae with dermapen in a stamping pattern until pin point bleeding appear. | Procedure or surgery | Group 1, Group 2 |
| Micro needle injection only* Disinfection: the affected area by alcohol 70 %. * Topical anesthetic cream will be applied: pridocaine (lidocaine 2.5% and prilocaine 2.5%) for 30 minutes under occlusion. * Microneedling with timolol 0.5% of the affected area will be done by derma pen that will be applied on the affected area as follows: inserting the sterilized needle into the derma pen tip, turning on using speed setting and adjusting speed on 5, needle depth of derma pen will be adjusted to (2- 2.5mm) according to the site of the striae, passing vertically over the striae with derma pen in a stamping pattern until pin point bleeding appear. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes
Time frame: 12 months
Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Zeinab baha Gouda, lecturer contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Micro needle injection and Micro needle injection only in people with Striae, run by Sohag University.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kholoud Moustafa Hashem, demonstator (+201092533978, kholed011080@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of combined microneedling plus tretinoin 0.025% or timolol 0.5% in treatment of stria rubra by noticing gradual changes in the appearance of skin and continuous photographing the site of lesion to notice the physiological changes (time frame: 12 months). 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 4 Sep 2025.