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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Triamcinolone Acetonide

Minoxidil 5 % Topical Spray

clobetasol propionate

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intralesional group

Topical therapy group

Arm Description

intralesional triamcinolone acetonide 5 mg/ml monthly

Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

ELISA

Quantitative measurement of Interleukin-23 (IL-23)

ELISA

Full Information

NCT ID

NCT03535233

First Posted

May 11, 2018

Last Updated

May 22, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03535233

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia Areata

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intralesional group

Arm Type

Active Comparator

Arm Description

intralesional triamcinolone acetonide 5 mg/ml monthly

Arm Title

Topical therapy group

Arm Type

Active Comparator

Arm Description

Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Intervention Type

Drug

Intervention Name(s)

Minoxidil 5 % Topical Spray

Intervention Type

Drug

Intervention Name(s)

clobetasol propionate

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Dermoscopic evaluation

Description

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

Time Frame

3 months

Title

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

Description

ELISA

Time Frame

3 months

Title

Quantitative measurement of Interleukin-23 (IL-23)

Description

ELISA

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials: