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Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Calcipotriol
Narrow Band UVB
vitamin D3 level
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia Areata, Calcipotriol, Narrow Band-UVB, Vitamin D3

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aswan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group I

Group II

Group III

Group IV

Arm Description

Outcomes

Primary Outcome Measures

Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score
calculation of SALT score before and after treatment
Improvement of serum Vitamin D levels in (ng/ml) after treatment
measurement of serum vitamin D before and after treatment

Secondary Outcome Measures

Full Information

First Posted
February 18, 2019
Last Updated
March 29, 2019
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03847441
Brief Title
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata
Official Title
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia Areata, Calcipotriol, Narrow Band-UVB, Vitamin D3

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Title
Group II
Arm Type
Active Comparator
Arm Title
Group III
Arm Type
Active Comparator
Arm Title
Group IV
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Calcipotriol
Intervention Description
Calcipotriol ointment (0.005%)
Intervention Type
Device
Intervention Name(s)
Narrow Band UVB
Intervention Description
NB-UVB (311nm) phototherapy
Intervention Type
Diagnostic Test
Intervention Name(s)
vitamin D3 level
Intervention Description
vitamin D3 (ng/ml)
Primary Outcome Measure Information:
Title
Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score
Description
calculation of SALT score before and after treatment
Time Frame
3 months
Title
Improvement of serum Vitamin D levels in (ng/ml) after treatment
Description
measurement of serum vitamin D before and after treatment
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata

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