Treatment of Striae AlbaphenytoinNCT07841366
Compairing Micro Needling With Phenytoin Versus Microneedling Alone on Striae Alba
A study testing Phenytoin and Micro needling in people with Treatment of Striae Alba, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Treatment of Striae Alba
- What is being tested?
- Phenytoin and Micro needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to 20 Jun 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with stria alba.
- The patient's age ≥18 years.
- Both sex male and Femal patients
- At least 3 stria
Who cannot join
- Pregnancy or lactation.
- Keloid or hypertrophic scar tendency
- Active skin infection at treatment site
- Use of isotretinoin within the past 6 months
- Bleeding disorders or anticoagulant therapy
- History of hypersensitivity to phenytoin
Show all 10Show fewer
- Chronic systemic diseases affecting wound healing (e.g., uncontrolled diabetes)
- Previous striae treatment within the last 6 months
- Unrealistic expectations or poor compliance
- Premalignant or malignant lesions in the treatment area
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar University, Faculty of Medicine for Girls
Cairo, Cairo Governorate, 11651
About this study
Official title: Comparing Microneedling With Phenytoin to Microneedling Alone for the Treatment of Striae Alba
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) .
The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%.
Read the detailed description
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) .
The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%.
All Patients will be evaluated during each session and 1 month after the last session.
All patients in this study will be subjected to the following:
- Written informed consent will be obtained from all patients after informing them about the steps of the procedures, the expected effects, the possible complications, other alternative treatments, and the importance of photo documentation.
- Full history taking:
- Personal history: Name, age, sex, residency, marital status, education, socio-economic status, special habits of medical importance, and occupational history.
- Present history: including onset, course, and duration of the lesions.
- Past history of any medical, or dermatological diseases and drug history.
- clinical Examination: *General examination: to detect any associated dermatological or systemic disorders.
- Local dermatological examination for detection of site, size, distribution and severity of stria alba .
- Detect severity of striae by Imam, Nelva, Alviera score (INA score) - Number of striae distensae lines, size of the longest striae distensae line, color and presence or absence of itching. The degrees of severity can be calculated per region are mild (score <3),moderate( score3-6)and sever (score >6).
The follow-up will include the following assessments: Evaluation by
- Evaluation by Digital Photography Standardized high-resolution digital photographs taken before and after treatment under consistent lighting conditions. 2- Evaluation by Detect severity of striae by Imam, Nelva, Alviera score (INA score) 3-Evaluation of pain subject discomfort will assessed using a 10-centimeter Visual Analog Scale (VAS) on a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be), 0-0.4 cm: No pain, 0.5-4.5 cm: Mild pain, 4.6-7.5 cm: Moderate pain, 7.6-10 cm: Severe pain
4 -Evaluation of Patient satisfaction (PS score) was recorded using the following scale: 0 (not satisfied), 1 (slightly satisfied), 2 (satisfied), 3 (very satisfied), 4 (extremely satisfied).
5-Patients will be assessed for any adverse effects including pain, edema, erosion, necrosis, and hyperpigmention.
- Conditions
- Treatment of Striae Alba
- Being tested
- Phenytoin, Micro needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenytoinDrug
striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycolwill be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle.
Micro needlingDevice
striae on the left side will be treated by microneedling alone with depth (2 mm) .
| Study group | Role | What they receive |
|---|---|---|
| Micro needling +Topical Phenytoin | Experimental | striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycol will be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle. Receives: Drug: Phenytoin; Device: Micro needling |
| Micro needling alone | Active comparator | striae on the left side will be treated by microneedling alone with depth (2 mm). Receives: Device: Micro needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in INA score of striae alba between treatment sides
Change in the INA score of striae alba from baseline to after completion of the four treatment sessions for each treatment side. The change in INA score will be compared between the right side treated with micro needling plus topical phenytoin and the left side treated with micro needling alone.,
Measured: baseline (before Session 1) and Week 9 (after completion of Session 4)
Change in INA score of striae Alba between treatment sides.
- The change in (INA) score of striae alba from baseline and 1 month after the last session for each treatment side. The change in INA score will be compared between the right side treated with microneedling plus topical phenytoin and the left side treated with microneedling alone.
Measured: Baseline (before Session 1), and 1 month after the last treatment session(weak 13).
Secondary outcomes (2)
Change in pain score
Pain intensity will be assessed using a visual analogue scale (VAS)on a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be), 0-0.4 cm: No pain, 0.5-4.5 cm: Mild pain, 4.6-7.5 cm: Moderate pain, 7.6-10 cm: Severe pain during each treatment session for both treatment sides. Pain scores will be compared between the right side treated with microneedling plus topical phenytoin and the left side treated with microneedling alone.
Measured: During each treatment session at Baseline (before Session 1), Week 3 (before Session 2), Week 6 (before Session 3), and Week 9 (before Session 4).
Change in Patient Satisfaction (PS) Score
Patient satisfaction will be assessed using the Patient Satisfaction (PS) score 0 (not satisfied), 1 (slightly satisfied), 2 (satisfied), 3 (very satisfied), 4 (extremely satisfied) after treatment( weak 9), and 1 month after the last treatment session for each treatment side. Changes in PS scores will be compared between the right side treated with micro needling plus topical phenytoin and the left side treated with micro needling alone.
Measured: Baseline, after treatment at fourth session(weak 9) , and 1 month after the last treatment session(weak13).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start15 Dec 2025
- Primary completion18 May 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Striae AlbaStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycol will be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Hamza Mahmoud Elbery, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841366
- Sponsor's protocol ID
- 2936
- Acronym
- phenytoin
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Microneedling With Phenytoin to Microneedling Alone for the Treatment of Striae Alba
- ClinicalTrials.gov ID
- NCT07841366
- Acronym / sponsor ID
- phenytoin / 2936
- Conditions
- Treatment of Striae Alba
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 25 Sep 2026 (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 the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) .
The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%.
Detailed description
The aim of this study is to evaluate the efficacy and safety of Microneedling with Phenytoin versus Microneedling alone for the Treatment of Striae alba.The study is a comparative study which will be carried on 30 patients with Striae alba. Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. -Left side: striae on the left side will be treated by microneedling alone with depth (2 mm) .
The follow up will be during each session and 1 months after the last session. For treated striae alba, Microneedling will be done under aseptic conditions using isopropyl alcohol 70%.
All Patients will be evaluated during each session and 1 month after the last session.
All patients in this study will be subjected to the following:
- Written informed consent will be obtained from all patients after informing them about the steps of the procedures, the expected effects, the possible complications, other alternative treatments, and the importance of photo documentation.
- Full history taking:
- Personal history: Name, age, sex, residency, marital status, education, socio-economic status, special habits of medical importance, and occupational history.
- Present history: including onset, course, and duration of the lesions.
- Past history of any medical, or dermatological diseases and drug history.
- clinical Examination: *General examination: to detect any associated dermatological or systemic disorders.
- Local dermatological examination for detection of site, size, distribution and severity of stria alba .
- Detect severity of striae by Imam, Nelva, Alviera score (INA score) - Number of striae distensae lines, size of the longest striae distensae line, color and presence or absence of itching. The degrees of severity can be calculated per region are mild (score <3),moderate( score3-6)and sever (score >6).
The follow-up will include the following assessments: Evaluation by
- Evaluation by Digital Photography Standardized high-resolution digital photographs taken before and after treatment under consistent lighting conditions. 2- Evaluation by Detect severity of striae by Imam, Nelva, Alviera score (INA score) 3-Evaluation of pain subject discomfort will assessed using a 10-centimeter Visual Analog Scale (VAS) on a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be), 0-0.4 cm: No pain, 0.5-4.5 cm: Mild pain, 4.6-7.5 cm: Moderate pain, 7.6-10 cm: Severe pain
4 -Evaluation of Patient satisfaction (PS score) was recorded using the following scale: 0 (not satisfied), 1 (slightly satisfied), 2 (satisfied), 3 (very satisfied), 4 (extremely satisfied).
5-Patients will be assessed for any adverse effects including pain, edema, erosion, necrosis, and hyperpigmention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patient will receive four sessions three weeks apart of the following treatment: -Right side: striae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycol will be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle.
| Arm | Type | Receives |
|---|---|---|
| Micro needling +Topical Phenytoin | Experimental | Drug: Phenytoin, Device: Micro needlingstriae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycol will be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle. |
| Micro needling alone | Active comparator | Device: Micro needlingstriae on the left side will be treated by microneedling alone with depth (2 mm). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with stria alba.
Key exclusion criteria (10 listed)
- Pregnancy or lactation.
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 |
|---|---|---|
| Phenytoinstriae on the right side will be treated by microneedling with depth (2 mm)with topical phenytoin 2% solution. A 2% Phenytoin topical solution will be prepared by dissolving the accurate amount of Phenytoin sodium in purified water using a magnetic stirrer. 15% propylene glycolwill be added to this solution as a cosolvent and a viscosity modifier. The formulation will be stirred using magnetic stirring up to complete dissolving. Finally, the prepared solution will be dispensed in an amber-colored glass bottle. | Drug | Micro needling +Topical Phenytoin |
| Micro needlingstriae on the left side will be treated by microneedling alone with depth (2 mm) . | Device | Micro needling +Topical Phenytoin, Micro needling alone |
Primary outcome
Change in INA score of striae alba between treatment sides
Time frame: baseline (before Session 1) and Week 9 (after completion of Session 4)
Change in the INA score of striae alba from baseline to after completion of the four treatment sessions for each treatment side. The change in INA score will be compared between the right side treated with micro needling plus topical phenytoin and the left side treated with micro needling alone.,
Change in INA score of striae Alba between treatment sides.
Time frame: Baseline (before Session 1), and 1 month after the last treatment session(weak 13).
- The change in (INA) score of striae alba from baseline and 1 month after the last session for each treatment side. The change in INA score will be compared between the right side treated with microneedling plus topical phenytoin and the left side treated with microneedling alone.
2 secondary outcomes
Change in pain score
Time frame: During each treatment session at Baseline (before Session 1), Week 3 (before Session 2), Week 6 (before Session 3), and Week 9 (before Session 4).
Change in Patient Satisfaction (PS) Score
Time frame: Baseline, after treatment at fourth session(weak 9) , and 1 month after the last treatment session(weak13).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenytoin and Micro needling in people with Treatment of Striae Alba, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 25 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in INA score of striae alba between treatment sides (time frame: baseline (before Session 1) and Week 9 (after completion of Session 4)). The study lists 2 primary outcomes in all. 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 25 Sep 2026.