Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata

Sponsor

Aswan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03847441

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: Calcipotriol Device: Narrow Band UVB Diagnostic Test: vitamin D3 level	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score [3 months]
calculation of SALT score before and after treatment
Improvement of serum Vitamin D levels in (ng/ml) after treatment [3 months]
measurement of serum vitamin D before and after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Feb 20, 2019

Last Update Posted:

Apr 2, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Moustafa A. El Taieb, Head of Dermatology, Venereology and Andrology Department, Ass. Prof. Principal Investigator, Aswan University Hospital

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2019