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

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ClinicalTrials.gov Identifier: NCT03535233
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Mona El-Kalioby, Cairo University

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


Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Triamcinolone Acetonide Drug: Minoxidil 5 % Topical Spray Drug: clobetasol propionate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535233


Sponsors and Collaborators
Cairo University
Investigators
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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

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Responsible Party: Mona El-Kalioby, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03535233     History of Changes
Other Study ID Numbers: AA22
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mona El-Kalioby, Cairo University:
Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Clobetasol
Minoxidil
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Vasodilator Agents