Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids
Primary Purpose
Alopecia Areata
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
the optimized sodium valproate-loaded nanospanlastic dispersion
mometasone furoate lotion
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring sodium valproate-loaded nanospanlastic, topical steroids, beta catenin, alopecia areata
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
Sites / Locations
- Kasralainy Hospital, Dermatology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
sodium valproate group
topical steroid group
Arm 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
Group 2 will be treated with the marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months
Outcomes
Primary Outcome Measures
- Treatment success
defined by achieving ≥ 50% reduction in baseline SALT score at end-of-study and/or achieving patient global assessment of improvement (PGAI) ≥ 50%.
Secondary Outcome Measures
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
Assessment of expression of both beta-catenin and Axin2 in lesional scalp of patients with patchy AA before and after treatment with sodium valproate-loaded nanospanlastics, in comparison to conventional therapy with topical steroids
Dermoscopic evaluation of hair regrowth
This evaluation will determine the number of dystrophic hairs in the patch area at baseline to be compared after the end of treatment. Markers for dystrophic hairs include exclamation-mark hairs, black dots, yellow dots and pigtail regrowing hair. The percentage of dystrophic hairs will be evaluated on a four-point scale: 3, > 50%; 2, 30-50%; 1, 1-29%; 0, no dystrophic hairs
Patient global assessment of improvement
Patient global assessment of improvement will be evaluated at the end of study, and will be scored as the following; (0 =no regrowth; 1 = <25% of regrowth; 2 = 25%-49% of regrowth; 3 = 50%-74% of regrowth; 4 = 75%-99% of re- growth; 5 = 100% of regrowth)
Clinical satisfaction of each patient
Clinical satisfaction of each patient will be made using a 10-point visual analogue scale (VAS, 0-10; the 0 level was defined as "Not satisfied at all," while a level of 10 was defined as "completely satisfied")
Subjective assessment of any encountered adverse effects
Subjective assessment of any encountered adverse effects (burning, itching) will also be performed. This will be determined on a four-point scale: 3, strong sensation; 2, moderate sensation; 1, mild sensation; 0, no itching or burning sensation
Patient satisfaction regarding characteristics of the used topical treatment
Patient satisfaction regarding characteristics of the used topical treatment, for example (texture, spreadability, hair matting, odour). This will be evaluated on a 3-point scale; 0=unsatisfied, 1=moderately satisfied, 2=extremely satisfied
Dermatology Life Quality Index (DLQI)
Dermatology Life Quality Index (DLQI) will be evaluated at baseline and at the end of therapy, using a validated DLQI questionaire
Assessment of relapse
Patients who achieved 100% reduction in baseline SALT after 3 months of treatment (end of therapy) were followed up for additional 3 months (end of study) to monitor any relapses.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05017454
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
sodium valproate-loaded nanospanlastic, topical steroids, beta catenin, alopecia areata
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sodium valproate group
Arm Type
Experimental
Arm 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
Arm Title
topical steroid group
Arm Type
Active Comparator
Arm Description
Group 2 will be treated with the marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months
Intervention Type
Drug
Intervention Name(s)
the optimized sodium valproate-loaded nanospanlastic dispersion
Intervention Description
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
Intervention Name(s)
mometasone furoate lotion
Intervention Description
participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months
Primary Outcome Measure Information:
Title
- Treatment success
Description
defined by achieving ≥ 50% reduction in baseline SALT score at end-of-study and/or achieving patient global assessment of improvement (PGAI) ≥ 50%.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
Assessment of expression of both beta-catenin and Axin2 in lesional scalp of patients with patchy AA before and after treatment with sodium valproate-loaded nanospanlastics, in comparison to conventional therapy with topical steroids
Time Frame
3 months
Title
Dermoscopic evaluation of hair regrowth
Description
This evaluation will determine the number of dystrophic hairs in the patch area at baseline to be compared after the end of treatment. Markers for dystrophic hairs include exclamation-mark hairs, black dots, yellow dots and pigtail regrowing hair. The percentage of dystrophic hairs will be evaluated on a four-point scale: 3, > 50%; 2, 30-50%; 1, 1-29%; 0, no dystrophic hairs
Time Frame
3 months
Title
Patient global assessment of improvement
Description
Patient global assessment of improvement will be evaluated at the end of study, and will be scored as the following; (0 =no regrowth; 1 = <25% of regrowth; 2 = 25%-49% of regrowth; 3 = 50%-74% of regrowth; 4 = 75%-99% of re- growth; 5 = 100% of regrowth)
Time Frame
3 months
Title
Clinical satisfaction of each patient
Description
Clinical satisfaction of each patient will be made using a 10-point visual analogue scale (VAS, 0-10; the 0 level was defined as "Not satisfied at all," while a level of 10 was defined as "completely satisfied")
Time Frame
3 months
Title
Subjective assessment of any encountered adverse effects
Description
Subjective assessment of any encountered adverse effects (burning, itching) will also be performed. This will be determined on a four-point scale: 3, strong sensation; 2, moderate sensation; 1, mild sensation; 0, no itching or burning sensation
Time Frame
3 months
Title
Patient satisfaction regarding characteristics of the used topical treatment
Description
Patient satisfaction regarding characteristics of the used topical treatment, for example (texture, spreadability, hair matting, odour). This will be evaluated on a 3-point scale; 0=unsatisfied, 1=moderately satisfied, 2=extremely satisfied
Time Frame
3 months
Title
Dermatology Life Quality Index (DLQI)
Description
Dermatology Life Quality Index (DLQI) will be evaluated at baseline and at the end of therapy, using a validated DLQI questionaire
Time Frame
3 months
Title
Assessment of relapse
Description
Patients who achieved 100% reduction in baseline SALT after 3 months of treatment (end of therapy) were followed up for additional 3 months (end of study) to monitor any relapses.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
heba ahmed, Msc in dermatolo
Organizational Affiliation
Kasralainy Hospital, Faculty of Medicine, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasralainy Hospital, Dermatology Department
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids
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