NCT03847441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

February 18, 2019

Last Update Submit

March 29, 2019

Conditions

Alopecia Areata

Keywords

Alopecia AreataCalcipotriolNarrow Band-UVBVitamin D3

Outcome Measures

Primary Outcomes (2)

  • Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score

    calculation of SALT score before and after treatment

    3 months

  • Improvement of serum Vitamin D levels in (ng/ml) after treatment

    measurement of serum vitamin D before and after treatment

    3 months

Study Arms (4)

Group I

ACTIVE COMPARATOR
Drug: CalcipotriolDiagnostic Test: vitamin D3 level

Group II

ACTIVE COMPARATOR
Device: Narrow Band UVBDiagnostic Test: vitamin D3 level

Group III

ACTIVE COMPARATOR
Drug: CalcipotriolDevice: Narrow Band UVBDiagnostic Test: vitamin D3 level

Group IV

PLACEBO COMPARATOR
Diagnostic Test: vitamin D3 level

Interventions

CalcipotriolDRUG

Calcipotriol ointment (0.005%)

Group IGroup III
Narrow Band UVBDEVICE

NB-UVB (311nm) phototherapy

Group IIGroup III
vitamin D3 levelDIAGNOSTIC_TEST

vitamin D3 (ng/ml)

Group IGroup IIGroup IIIGroup IV

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Alopecia Areata of scalp

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Dermatology, Venereology and Andrology Department, Ass. Prof. Principal Investigator

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 20, 2019

Study Start

October 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)