NCT05684861

Brief Summary

Evaluate the serum level of TWEAK in patients with AV and their relations before and after treatment with isotretinoin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

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

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 1, 2023

Last Update Submit

January 5, 2023

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • serum level of TWEAK

    To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.

    12 weeks

Secondary Outcomes (1)

  • evaluate the effect of systemic isotretinoin on serum TWEAK level

    12 weeks

Study Arms (2)

Group I patients

ACTIVE COMPARATOR

90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases

Drug: IsotretinoinDiagnostic Test: ELISA Assays of Serum TWEAK.

Control group

ACTIVE COMPARATOR

60 age-sex-matched healthy subjects as a control group

Diagnostic Test: ELISA Assays of Serum TWEAK.

Interventions

IsotretinoinDRUG

systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months

Group I patients
ELISA Assays of Serum TWEAK.DIAGNOSTIC_TEST

: From each subject, 5mL of blood was collected into vacutainers before and after treatment with isotretinoin. The blood samples were centrifuged at 3000g for 10 min at a temperature of 4°C, then . Quantitative determinations for serum TWEAK were achieved using the corresponding commercially available ELISA kit supplied by the AssayMax

Control groupGroup I patients

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases

You may not qualify if:

  • Pregnant and lactating women, patients with renal, GIT, skeletal, psychiatric, and endocrine disorders, sarcoidosis, and patients receiving drugs such as diuretics, multivitamins, anticonvulsants, glucocorticoids, erythromycin, estrogen compound pill were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University

Qina, Qena Governorate, 83522, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Hassan M Ibrahim, professor

    South Valley University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 13, 2023

Study Start

January 1, 2022

Primary Completion

December 20, 2022

Study Completion

January 1, 2023

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)