Compairing Micro Needling With Phenytoin Versus Microneedling Alone on Striae Alba

NCT07841366 | Completed

• 1 other identifier: 2936
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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%.

Conditions

Treatment of Striae Alba

Outcome Measures

Primary Outcomes (2)

• 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.,

  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.

  Baseline (before Session 1), and 1 month after the last treatment session(weak 13).

Secondary Outcomes (2)

• Change in pain score

  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

  Baseline, after treatment at fourth session(weak 9) , and 1 month after the last treatment session(weak13).

Study Arms (2)

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.

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).

Device: Micro needling

Interventions

Phenytoin DRUG

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 needling +Topical Phenytoin

Micro needling DEVICE

striae on the left side will be treated by microneedling alone with depth (2 mm) .

Micro needling +Topical Phenytoin; Micro needling alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with stria alba.
• The patient's age ≥18 years.
• Both sex male and Femal patients
• At least 3 stria

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University, Faculty of Medicine for Girls

Cairo, Cairo Governorate, 11651, Egypt

Location

MeSH Terms

Interventions

Phenytoin

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Resident

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 25, 2026
• Study Start: December 15, 2025
• Primary Completion: May 18, 2026
• Study Completion: June 20, 2026
• Last Updated: September 25, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)