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

NCT03535233 | Completed Phase 4

• 1 other identifier: AA22
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Alopecia Areata

Keywords

Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dermoscopic evaluation

  3 months

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

  3 months

• Quantitative measurement of Interleukin-23 (IL-23)

  3 months

Study Arms (2)

Intralesional group

ACTIVE COMPARATOR

intralesional triamcinolone acetonide 5 mg/ml monthly

Drug: Triamcinolone Acetonide

Topical therapy group

ACTIVE COMPARATOR

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

Interventions

Triamcinolone Acetonide DRUG

Intralesional group

Minoxidil 5 % Topical Spray DRUG

Topical therapy group

clobetasol propionate DRUG

Topical therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone Acetonide; Minoxidil; Clobetasol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Betamethasone

Study Officials

• Nermine H El-Eishi, MD

  Cairo University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 24, 2018
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 24, 2018

Record last verified: 2018-05