NCT04412148

Brief Summary

Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 29, 2020

Last Update Submit

May 29, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percentage involvement

    Degree of severity expressed as a percentage

    6months to 1 year

  • Modified Severity of Alopecia Tool (mSALT) score

    New Score calculating severity (hair density) and area as a number minimum value is 0 and maximum value is 105 the higher the number of the score the worse the affection

    6 months to 1 year

Study Arms (2)

Intralesional Steroids

ACTIVE COMPARATOR
Drug: Triamcinolone Acetonide

Control

PLACEBO COMPARATOR
Other: saline

Interventions

intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions

Intralesional Steroids
salineOTHER

intralesional injection of saline

Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent.

You may not qualify if:

  • pregnant, and lactating females
  • Alopecia totalis or universalis or ophiasis or cicatritial alopecia
  • Usage of systemic treatment of alopecia areata 2 months prior to the study.
  • Any scalp lesion within the treated area
  • Bleeding diathesis, severe anemia or platelet disorders
  • Medical conditions such as autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainy university hospital, Faulty of medicine,Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

Triamcinolone AcetonideSodium Chloride

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 2, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations