Clinical trial NCT05017454: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alopecia Areata
Keywords: sodium valproate-loaded nanospanlastic
topical steroids
beta catenin
alopecia areata
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: - Treatment success
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
measure: Dermoscopic evaluation of hair regrowth
timeFrame: 3 months
measure: Patient global assessment of improvement
timeFrame: 3 months
measure: Clinical satisfaction of each patient
timeFrame: 3 months
measure: Subjective assessment of any encountered adverse effects
timeFrame: 3 months
measure: Patient satisfaction regarding characteristics of the used topical treatment
timeFrame: 3 months
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 3 months
measure: Assessment of relapse
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy Hospital, Dermatology Department
Study officials:
affiliation: Kasralainy Hospital, Faculty of Medicine, Cairo University
name: heba ahmed, Msc in dermatolo
role: PRINCIPAL_INVESTIGATOR
References: