Atrophic Acne ScarPhase 4NCT06942468
Phenytoin in Treatment of Atrophic Post Acne Scars.
A Phase 4 study testing Topical nano preparation of Phenytoin and Fractional CO2 laser in people with Atrophic Acne Scar, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- Topical nano preparation of Phenytoin and Fractional CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Aug 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged equal or more than 18 years old with atrophic post acne scars.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrophic Acne Scar
- Being tested
- Topical nano preparation of Phenytoin, Fractional CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical nano preparation of PhenytoinDrug
Also called Topical Phenytoin
Topical nano preparation of Phenytoin will be used to treat atrophic post-acne scars. It will be in form of spanlastics.
Fractional CO2 laserDevice
Fractional CO2 laser will be used alone for treatment of atrophic post acne scars.
| Study group | Role | What they receive |
|---|---|---|
| Topical Phenytoin and Fractional CO2 laser | Experimental | Topical Phenytoin and Fractional CO2 laser will be used in combinaton to treat atrophic post-acne scars. Receives: Drug: Topical nano preparation of Phenytoin |
| Fractional CO2 laser alone | Experimental | Fractional CO2 laser will be used alone to treat atrophic post acne scars. Receives: Device: Fractional CO2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately at the end of the treatment and 2 months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrophic Acne ScarStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Abdalla Sultan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942468
- Sponsor's protocol ID
- Phenytoin in post acne scars.
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38807440Rivera 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.
PubMed 18662839
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06942468
- Acronym / sponsor ID
- Phenytoin in post acne scars.
- Conditions
- Atrophic Acne Scar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Apr 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Phenytoin and Fractional CO2 laser | Experimental | Drug: Topical nano preparation of PhenytoinTopical Phenytoin and Fractional CO2 laser will be used in combinaton to treat atrophic post-acne scars. |
| Fractional CO2 laser alone | Experimental | Device: Fractional CO2 laserFractional CO2 laser will be used alone to treat atrophic post acne scars. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged equal or more than 18 years old with atrophic post acne scars.
Key exclusion criteria (6 listed)
- 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).
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 |
|---|---|---|
| Topical nano preparation of PhenytoinAlso: Topical PhenytoinTopical nano preparation of Phenytoin will be used to treat atrophic post-acne scars. It will be in form of spanlastics. | Drug | Topical Phenytoin and Fractional CO2 laser |
| Fractional CO2 laserFractional CO2 laser will be used alone for treatment of atrophic post acne scars. | Device | Fractional CO2 laser alone |
Primary outcome
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.
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 24 Apr 2025.
- Background: PubMed 38807440Sadeghzadeh-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.
- Background: PubMed 18662839Rivera 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.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical nano preparation of Phenytoin and Fractional CO2 laser in people with Atrophic Acne Scar, run by Assiut 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 6 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 24 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Shaimaa Mohamed Sultan, Dermatologist resident (+2 01144682538, shaima.15235426@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06942468, which also lists 2 linked publications.
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 24 Apr 2025.