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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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
- 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
- Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1) [ Time Frame: 3 months ]ELISA
- Quantitative measurement of Interleukin-23 (IL-23) [ Time Frame: 3 months ]ELISA
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
|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|