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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535233
• Other study ID #: AA22
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Triamcinolone Acetonide

• Minoxidil 5 % Topical Spray

• clobetasol propionate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quantitative measurement of Transforming growth factor-beta 1 (TGF-ß1)	ELISA	3 months
Secondary	Quantitative measurement of Interleukin-23 (IL-23)	ELISA	3 months