Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.
Primary Purpose
Acne Vulgaris
Status
Completed
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:
- Patients of both sexes with acne vulgaris
Exclusion Criteria:
- Patients with history of malignancies.
- Patients with renal and hepatic dysfunction.
- Cardiac patient.
- Pregnant, lactating and female welling to have pregnancy in the period of study.
- Patient with absorption disorder.
- Patient with history of favism.
- Patient has already been treated with isotretinoin.
Sites / Locations
- Aswan University-Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Patient group
Control group
Arm Description
Patients were treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum homocysteine were assessed before and after treatment
Assessment of serum YKL40 in healthy individuals
Outcomes
Primary Outcome Measures
Evaluation of the effect of oral isotretinoin on Serum homocysteine in acne vulgaris patients
Assessment in serum level homocysteine level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum homocysteine and effect of isotretinoin therapy on it.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05529888
Brief Title
Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.
Official Title
Serum Homocysteine Level in Acne Patients Before and After Oral Isotretinoin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University
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
Serum homocysteine level in Acne patients before and after oral Isotretinoin and Correlation between serum level of homocysteine in acne patients before and after Oral isotretinoin treatment
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 homocysteine level in acne patient befor and after oral isotrtinoin 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
Model Description
group of patients and group of control
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient group
Arm Type
Active Comparator
Arm Description
Patients were treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum homocysteine were 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 Serum homocysteine in acne vulgaris patients
Description
Assessment in serum level homocysteine level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum homocysteine 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
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes with acne vulgaris
Exclusion Criteria:
Patients with history of malignancies.
Patients with renal and hepatic dysfunction.
Cardiac patient.
Pregnant, lactating and female welling to have pregnancy in the period of study.
Patient with absorption disorder.
Patient with history of favism.
Patient has already been treated with isotretinoin.
Facility Information:
Facility Name
Aswan University-Faculty of Medicine
City
Aswan
State/Province
New Aswan City
ZIP/Postal Code
81528
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.
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