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Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847441
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Moustafa A. El Taieb, Aswan University Hospital

Brief Summary:
Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum vitamin D3 levels.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Calcipotriol Device: Narrow Band UVB Diagnostic Test: vitamin D3 level Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Group I Drug: Calcipotriol
Calcipotriol ointment (0.005%)

Diagnostic Test: vitamin D3 level
vitamin D3 (ng/ml)

Active Comparator: Group II Device: Narrow Band UVB
NB-UVB (311nm) phototherapy

Diagnostic Test: vitamin D3 level
vitamin D3 (ng/ml)

Active Comparator: Group III Drug: Calcipotriol
Calcipotriol ointment (0.005%)

Device: Narrow Band UVB
NB-UVB (311nm) phototherapy

Diagnostic Test: vitamin D3 level
vitamin D3 (ng/ml)

Placebo Comparator: Group IV Diagnostic Test: vitamin D3 level
vitamin D3 (ng/ml)




Primary Outcome Measures :
  1. Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score [ Time Frame: 3 months ]
    calculation of SALT score before and after treatment

  2. Improvement of serum Vitamin D levels in (ng/ml) after treatment [ Time Frame: 3 months ]
    measurement of serum vitamin D before and after treatment



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alopecia Areata of scalp

Exclusion Criteria:

Other causes of alopecias including scarring alopecia, androgenic alopecia, telogen effluvium autoimmune diseases, pregnant and lactating females


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): NCT03847441


Locations
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Egypt
Aswan University Hospital
Aswan, Egypt, 81528
Sponsors and Collaborators
Aswan University Hospital
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Responsible Party: Moustafa A. El Taieb, Head of Dermatology, Venereology and Andrology Department, Ass. Prof. Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03847441    
Other Study ID Numbers: Alopecia Calcipotiol
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Moustafa A. El Taieb, Aswan University Hospital:
Alopecia Areata
Calcipotriol
Narrow Band-UVB
Vitamin D3
Additional relevant MeSH terms:
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Hair Diseases
Vitamin D
Vitamins
Alopecia
Alopecia Areata
Hypotrichosis
Skin Diseases
Pathological Conditions, Anatomical
Cholecalciferol
Calcipotriene
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Dermatologic Agents