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NCT Number: NCT03535233

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

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

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone Acetonide

Drug

Minoxidil 5 % Topical Spray

Drug

Clobetasol propionate

Drug

Primary outcomes

  1. Clinical assessment using SALT score (Severity of Alopecia Tool score)

    Time frame: 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 outcomes

  1. Dermoscopic evaluation

    Time frame: 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

  2. Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1)

    Time frame: 3 months

    ELISA

  3. Quantitative measurement of Interleukin-23 (IL-23)

    Time frame: 3 months

    ELISA

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 24, 2018
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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