Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata
- Conditions
- Alopecia Areata
- Interventions
- Registration Number
- NCT03535233
- Lead Sponsor
- Cairo University
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical therapy group Minoxidil 5 % Topical Spray Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night Intralesional group Triamcinolone Acetonide intralesional triamcinolone acetonide 5 mg/ml monthly Topical therapy group clobetasol propionate Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night
- Primary Outcome Measures
Name Time Method Clinical assessment using SALT score (Severity of Alopecia Tool score) 3 months 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
- Secondary Outcome Measures
Name Time Method Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1) 3 months ELISA
Quantitative measurement of Interleukin-23 (IL-23) 3 months ELISA
Dermoscopic evaluation 3 months 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