Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids

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Brief Title

Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids

Official Title

Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Asessements

Brief Summary

      the aim of this study is to assess the efficacy and safety of sodium valproate-loaded
      nanospanlastic in the treatment of patchy AA, in comparison to conventional therapy with
      topical steroids
    

Detailed Description

      Alpopecia Areata (AA) is the second common cause of non-scarring hair loss, the disease has
      huge negative impact on patients' quality of life, social and psychological status. The
      underlying pathogenesis of AA is not fully characterized, Yet the collapse of immune
      privilege and generation of autoimmune attack against unknown follicular antigens are the
      most agreed-upon theories behind the disease. In spite of various therapeutic armamentariums
      available for AA, no single agent has been proven efficacious regarding reversing hair loss
      and establishing long-term response.

      keeping in mind the burden of the disease together with lacking effective treatments, a need
      for further therapies is colossal.

      Wnt-b catenin pathway is one of the crucial signalling pathways that regulate hair cycling.
      An increasing body of evidence is supporting the fact that wnt-b catenin pathway is inhibited
      in AA, and therefore contributing to the hair loss that characteize the disease.

      Sodium valproate (SV), a well-known anti-epileptic drug, was found to inhibit Glycogen
      synthase kinase-3beta (GSK3β) in neuronal cells as one of the possible antiepileptic
      mechanisms of SV. GSK3B is a well-known inhibitor of β-catenin activity in dermal papilla
      cells (DPCs), and thus induces catagen-like changes in these cells. So the idea of using
      topical SV to promote hair regrowth via activation of b catenin came up and attracted the
      interests of investigators. recently an optimized sodium valproate-loaded nanospanlastics
      topical formula promisingly achieved clinical equivalence with 5% minoxidil lotion in AGA,
      with a superior safety profile to minoxidil
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Assessment of treatment success rate of SV-loaded nanospanlastics in the treatment of mild to moderate patchy AA in comparison to conventional therapy with topical steroids

Secondary Outcome

 molecular Assessment of treatment success rate of SV-loaded nanospanlastics in the treatment of mild to moderate patchy AA in comparison to conventional therapy with topical steroids

Condition

Alopecia Areata

Intervention

the optimized sodium valproate-loaded nanospanlastic dispersion

Study Arms / Comparison Groups

 sodium valproate group
Description:  Group 1 will be treated with the optimized sodium valproate-loaded nanospanlastic dispersion, twice daily on the affected areas of the scalp for 3 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

64

Start Date

January 1, 2022

Completion Date

April 1, 2023

Primary Completion Date

January 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with mild to moderate patchy alopecia areata, which is defined as less than
             50% involvement of the entire scalp

          -  Age above 12 years.

          -  Both genders.

          -  Patients with patchy alopecia areata, with 2 patches or more

        Exclusion Criteria:

          -  Patients having single patch alopecia areata (at least 2 patches are required, as one
             patch will be left untreated to exclude the possibility of spontaneous remission)

          -  Affection of more than 50% of the scalp area

          -  Patients with alopecia totalis or universalis

          -  Patients with ophiasis

          -  Age: Less than 12 years old.

          -  Pregnant or lactating females

          -  Patients with history of or existing scalp skin diseases, infections or skin cancer

          -  Severe systemic illness (as uncontrolled DM or hypertension, liver or renal diseases)
             and immune-compromised patients

          -  Patients with concomitant autoimmune diseases as suspected by history or confirmed by
             previous investigations

          -  Diagnosis or history of local dermatological disease in the scalp apart from AA such
             as eczema, seborrheic dermatitis, psoriasis.

          -  Any psychiatric illness or psychological state impairing future compliance or
             influencing expectations of the patient
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

heba ahmed, Msc in dermatolo, 0201016532351, [email protected]

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations


NCT ID

NCT05017454

Organization ID

264199200


Responsible Party

Principal Investigator

Study Sponsor

Kasr El Aini Hospital


Study Sponsor

heba ahmed, Msc in dermatolo, Principal Investigator, dermatology resident at kasralainy hospital, faculty of medicine, cairo university


Verification Date

August 2021