Phenytoin in Treatment of Atrophic Post Acne Scars.

NCT06942468 | Not Yet Recruiting Phase 4

• 1 other identifier: Phenytoin in post acne scars.
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of topical phenytoin spanlastics as an adjuvant therapy in treatment of atrophic post acne scars. To compare the efficacy of topical phenytoin spanlastics combined with fractional co2 laser versus fractional co2 laser alone in treatment of atrophic post acne scars.

Conditions

Atrophic Acne Scar

Outcome Measures

Primary Outcomes (1)

• To assess the Quantitative Global Acne Scarring score before.

  * The Quantitative Global Scarring Grading System uses a scale of 0 to 84 * The scale assesses the severity of scarring based on the appearance, depth, and area of the scars.

  Immediately at the end of the treatment and 2 months after the end of the treatment

Study Arms (2)

Topical Phenytoin and Fractional CO2 laser

EXPERIMENTAL

Topical Phenytoin and Fractional CO2 laser will be used in combinaton to treat atrophic post-acne scars.

Drug: Topical nano preparation of Phenytoin

Fractional CO2 laser alone

EXPERIMENTAL

Fractional CO2 laser will be used alone to treat atrophic post acne scars.

Device: Fractional CO2 laser

Interventions

Topical nano preparation of Phenytoin DRUG

Topical nano preparation of Phenytoin will be used to treat atrophic post-acne scars. It will be in form of spanlastics.

Also known as: Topical Phenytoin

Topical Phenytoin and Fractional CO2 laser

Fractional CO2 laser DEVICE

Fractional CO2 laser will be used alone for treatment of atrophic post acne scars.

Fractional CO2 laser alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged equal or more than 18 years old with atrophic post acne scars.

You may not qualify if:

• Pregnancy and lactation
• Hypertrophic scars
• Kidney, liver, neurological, haematological, malignant or immunosuppressive diseases.
• Active infection at the site of the scars
• Patients use medications that reduced tissue healing during the study or in a period less than one month ago (immunosuppressants and isotretinoin).
• Patients who are taking anticoagulants or NSAIDS within the past 48h.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Sadeghzadeh-Bazargan A, Pashaei A, Ghassemi M, Dehghani A, Shafiei M, Goodarzi A. Evaluation and comparison of the efficacy and safety of the combination of topical phenytoin and microneedling with microneedling alone in the treatment of atrophic acne scars: A controlled blinded randomized clinical trial. Skin Res Technol. 2024 Jun;30(6):e13766. doi: 10.1111/srt.13766.

  PMID: 38807440 BACKGROUND

• Rivera AE. Acne scarring: a review and current treatment modalities. J Am Acad Dermatol. 2008 Oct;59(4):659-76. doi: 10.1016/j.jaad.2008.05.029. Epub 2008 Jul 26.

  PMID: 18662839 BACKGROUND

MeSH Terms

Interventions

Phenytoin

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Shaimaa Mohamed Sultan, Dermatologist resident

CONTACT

+2 01144682538; shaima.15235426@med.aun.edu.eg

Eman Mohamed Kamal El-sayed, Professor

CONTACT

+2 01005369338; emankyoussef@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist resident

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-04