Phenytoin in Treatment of Atrophic Post Acne Scars.

April 16, 2025 updated by: Shaimaa Mohamed Abdalla Sultan, Assiut University

Efficacy and Safety of Topical Nano Preparation of Phenytoin Plus Fractional CO2 Laser Versus Fractional CO2 Laser Alone for Treatment of Atrophic Post Acne Scars: A Randomized Split Face Study.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acne is one of the most dermatological problems in the world which causes scars as secondary damage .

It affects the appearance and psychology of the patient badly . There are three main types of scars: atrophic, hypertrophic, or keloidal depending on a loss (atophic) or gain (hypertrophic and keloidal) of collagen .

Atrophic scars presented in the form of icepick, rolling and poxscar . It is a challenge to mange atrophic scars because these scars result from tissue loss during the healing after severe acne. There are many therapeutic techniques that continuously evolving for management of these scars as: fractional lasers, microneedling, chemical peels and dermabrasion .

Phenytoin (PHT) is the main treatment for epilepsy. However, many patients who took it show gingival hyperplasia . Phenytoin causes increased fibroblasts proliferation. It has the ability to reduce the oedema and inflammation at the wound base and margins, early separation of slough, and collagen production and acceleration of growth of healthy granulation tissues, so it can be used in healing .

By induction of collagen synthesis and reducing inflammation, topical phenytoin can alleviate the appearance of atrophic scars including acne scars and improve their texture. Application of phenytoin directly to affected areas may lead to significant improvements in scarred skin over regular and consistent usage .

To the best of our knowledge, only one study has investigated the healing potential of PHT cream with microneedling application for the management of atrophic acne scars .

Nevertheless, its limited solubility, bioavailability, and inefficient distribution during topical administration limit its use. Nanopreparation of phenytoin showed promising findings that encourage the potential use of phenytoin loaded lipid nanoparticles for future topical application.

Spanlastics are composed of a non-ionic surfactant and an edge activator (EA). The presence of EA confers the penetration-enhancing effect of spanlastics that facilitate topical drug delivery. Spanlastics squeeze themselves through skin pores without being disrupted due to their elastic, deformable nature. Besides, spanlastics are non-immunogenic, biodegradable systems that are compatible with biological membrane with minimum toxicity. Given these premises of spanlastics as topical drug delivery systems, the current study is set to explore their features to enhance the penetration of phenytoin, control its release, and improve its efficacy in the management of atrophic acne scars.

Fractional carbon dioxide laser (CO2 laser) is the gold standard for the treatment of atrophic acne scars and skin rejuvenation . Its wavelength is 10,600nm. It targets water containing cells, which is its chromophore . It thermally acts on a portion of the skin creating numerous microthermal treatment zones leaving normal skin intact in between, which rapidly regenerates the ablated columns of tissue. Thermal injury induces coagulation and denaturation of collagen and reepithelialisation .

CO2 lasers have a double effect as they induce renewable processes of the wound and increase production of myofibroblasts and matrix proteins such as the hyaluronic acid.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Phenytoin and Fractional CO2 laser
Topical Phenytoin and Fractional CO2 laser will be used in combinaton to treat atrophic post-acne scars.
Drug: Topical nano preparation of Phenytoin
Topical nano preparation of Phenytoin will be used to treat atrophic post-acne scars. It will be in form of spanlastics.
Other Names:
  • Topical Phenytoin
Experimental: Fractional CO2 laser alone
Fractional CO2 laser will be used alone to treat atrophic post acne scars.
Device: Fractional CO2 laser
Fractional CO2 laser will be used alone for treatment of atrophic post acne scars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the Quantitative Global Acne Scarring score before.
Time Frame: Immediately at the end of the treatment and 2 months after the end of the treatment
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phenytoin in post acne scars.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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