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

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

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

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Triamcinolone Acetonide; Drug: Minoxidil 5 % Topical Spray; Drug: clobetasol propionate

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Nermine H El-Eishi, MD, Cairo university; Principal Investigator: Heba M Mashaly, MD, Cairo university; Principal Investigator: Solwan I El-Samanoudy, MD, Cairo university; Principal Investigator: Mona MI ElKalioby, MD, Cairo university; Principal Investigator: Olfat G Shaker, MD, Cairo university; Principal Investigator: Rania M Abdel-Hay, MD, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Clobetasol; Minoxidil
• Other Study ID Numbers: AA22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No