Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata

Study Overview
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Brief Summary
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Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few. The aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia areata

Official Title
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Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial

Conditions
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Alopecia Areata

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Drug: Minoxidil 5 % Topical Spray
* Drug: clobetasol propionate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration. Exclusion Criteria: Alopecia totalis and alopecia universalis. Alopecia areata solely affecting the beard. Pregnant and lactating. Patients known to have autoimmune diseases e.g. autoimmune thyroid disease, vitiligo or SLE. Patients receiving systemic treatment relevant to alopecia areata within 3 months before enrollment into the study or topical treatment relevant to alopecia areata within 2 months before. Patients with a dermatological condition affecting the scalp other than AA: e.g. psoriasis, eczema. Patients with psychiatric illness or psychological state interfering with compliance or influencing the expectation of the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intralesional group<br>intralesional triamcinolone acetonide 5 mg/ml monthly | Drug: Triamcinolone Acetonide<br> <br> |
| Active Comparator: Topical therapy group<br>Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night | Drug: Minoxidil 5 % Topical Spray<br> <br> Drug: clobetasol propionate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment using SALT score (Severity of Alopecia Tool score) | SALT score is a quantitative assessment scale for the evaluation of percentage of scalp hair loss. The percent surface area of each of the 4 scalp is determined: Vertex (top): 40% (0.4) of scalp surface area; each side of scalp (right and left profile): each 18% (0.18) of scalp surface area; posterior aspect (back) of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these 4 aspects is calculated as the percentage of hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of product of each section in the above mentioned areas. SALT score is calculated before and after therapy. Lowest value: 0%: indicates abscence of clinical disease, Highest value: 100%: indicate 100% affection of the scalp | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermoscopic evaluation | Dermoscopic assessment of the scalp is performed using DermaLite II Pro HR dermoscope, Germany. Dermoscopic examination is graded according to a scale provided by Trink and colleagues (2013). The percentage of dystrophic hairs was evaluated on a 4-point scale as followed: 3= >50% dystrophic hairs 2 = 30-50% dystrophic hairs 1 = 1-29% dystrophic hairs 0 = no dystrophic hairs | 3 months | 
| Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1) | ELISA | 3 months | 
| Quantitative measurement of Interleukin-23 (IL-23) | ELISA | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1