Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients
Primary Purpose
Acne Vulgaris
Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
About this trial
This is an interventional diagnostic trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Healthy persons of both sexes with moderate and severe acne.
- Age above 14 years.
Exclusion Criteria:
- 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.
- History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
- Cases with known hypersensitivity reaction to isotretinoin.
Sites / Locations
- Aswan university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Isotretinoin group
Control group
Arm Description
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
Assessment of serum YKL40 in healthy individuals
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05218486
First Posted
January 5, 2022
Last Updated
September 1, 2022
Sponsor
Alshimaa Abbas Mohamed Ebrahim
1. Study Identification
Unique Protocol Identification Number
NCT05218486
Brief Title
Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients
Official Title
Evaluation of The Effect of Oral Isotretinoin on The Level of Serum YKL40 in Acne Vulgaris Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alshimaa Abbas Mohamed Ebrahim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
Detailed Description
Acne vulgaris is a common chronic inflammatory disease of the skin. It is found in about 80% of young adults and adolescents. It is a disease that affects the pilosebaceous units of the skin and may result in inflammatory or non-inflammatory lesions,Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne .The standard dose of isotretinoin is 0.5 to 1 mg/kg per day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne vulgaris The scope of our study is to detect serum YKL-40 level in acne patient before and after oral isotretinoin treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Isotretinoin group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Assessment of serum YKL40 in healthy individuals
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy persons of both sexes with moderate and severe acne.
Age above 14 years.
Exclusion Criteria:
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.
History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
Cases with known hypersensitivity reaction to isotretinoin.
Facility Information:
Facility Name
Aswan university
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients
We'll reach out to this number within 24 hrs