Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients

Sponsor
Alshimaa Abbas Mohamed Ebrahim (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05218486
Collaborator
(none)
60
1
2
12
5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of The Effect of Oral Isotretinoin on The Level of Serum YKL40 in Acne Vulgaris Patients
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jun 15, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Isotretinoin group

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
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

No Intervention: Control group

Assessment of serum YKL40 in healthy individuals

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients. [3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Healthy persons of both sexes with moderate and severe acne.

  2. Age above 14 years.

Exclusion Criteria:
  1. Pregnant and lactating women, immunocompromised patients.

  2. History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease.

  3. History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.

  4. Cases with known hypersensitivity reaction to isotretinoin.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aswan university Aswan Egypt 81528

Sponsors and Collaborators

  • Alshimaa Abbas Mohamed Ebrahim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alshimaa Abbas Mohamed Ebrahim, principal investigator, Aswan University
ClinicalTrials.gov Identifier:
NCT05218486
Other Study ID Numbers:
  • 551/7/21
First Posted:
Feb 1, 2022
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022