NCT05218486

Brief Summary

The aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.

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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2021

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

August 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

January 5, 2022

Last Update Submit

September 1, 2022

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.

    Assessment in serum level YKL40 level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum YKL40 and effect of isotretinoin therapy on it.

    3 months

Study Arms (2)

Isotretinoin group

ACTIVE COMPARATOR

Patients will be treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum YKL40 will be assessed before and after treatment

Drug: Isotretinoin

Control group

NO INTERVENTION

Assessment of serum YKL40 in healthy individuals

Interventions

IsotretinoinDRUG

Isotretinoin is a vitamin-A derivative for treatment of moderate to severe acne used in a dose from 20-40 mg for 3 months duration

Isotretinoin group

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy persons of both sexes with moderate and severe acne.
  • Age above 14 years.

You may not qualify if:

  • Pregnant and lactating women, immunocompromised patients.
  • History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease.
  • Cases with known hypersensitivity reaction to isotretinoin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan university

Aswān, 81528, 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 Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

February 1, 2022

Study Start

August 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

September 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)