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

NCT ID: NCT05017454

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-04-01

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

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sodium valproate group

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

Group Type: EXPERIMENTAL

the optimized sodium valproate-loaded nanospanlastic dispersion

Intervention Type: DRUG

participants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months

topical steroid group

Group 2 will be treated with the marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months

Group Type: ACTIVE_COMPARATOR

mometasone furoate lotion

Intervention Type: DRUG

participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months

Interventions

the optimized sodium valproate-loaded nanospanlastic dispersion

participants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months

Intervention Type: DRUG

mometasone furoate lotion

participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

heba ahmed abdelgayed ibrahim

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

heba ahmed, Msc in dermatolo

Role: PRINCIPAL_INVESTIGATOR

Kasralainy Hospital, Faculty of Medicine, Cairo University

Locations

Kasralainy Hospital, Dermatology Department

Cairo, , Egypt

Countries

Egypt

References

Mogawer RM, Fawzy MM, Mourad A, Ahmed H, Nasr M, Nour ZA, Hafez V. Topical sodium valproate-loaded nanospanlastics versus conventional topical steroid therapy in alopecia areata: a randomized controlled study. Arch Dermatol Res. 2024 Jan 3;316(2):64. doi: 10.1007/s00403-023-02785-1.

Reference Type: DERIVED

PMID: 38170256 (View on PubMed)

Other Identifiers

264199200

Identifier Type: -

Identifier Source: org_study_id