Topical nano preparation of Phenytoin
DrugTopical nano preparation of Phenytoin will be used to treat atrophic post-acne scars. It will be in form of spanlastics.
Other names: Topical Phenytoin
NCT Number: NCT06942468
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Fractional CO2 laser will be used alone for treatment of atrophic post acne scars.
Time frame: Immediately at the end of the treatment and 2 months after the end of the treatment
Contact information is provided by the study sponsor or research team.
Eman Mohamed Kamal El-sayed, Professor
CONTACT
Shaimaa Mohamed Sultan, Dermatologist resident
CONTACT
Assiut University
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07199608
Atrophic Acne Scar
Asyut, Asyut Governorate, Egypt
View Trial DetailsNCT07028567
Atrophic Acne Scar, Calcium Hydroxylapatite
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT06789874
Atrophic Acne Scar, Atrophic Acne Scarring
Rahimyarkhan, Punjab Province, Pakistan
View Trial DetailsNCT06580691
Acne Vulgaris, Acneiform Eruptions
Tanta, Gharbia Governorate, Egypt
View Trial Details