Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.

September 3, 2022 updated by: Doaa Hamdi Abd Elal Mohamed, Aswan University

Serum Homocysteine Level in Acne Patients Before and After Oral Isotretinoin

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

Study Overview

Status

Completed

Conditions

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • New Aswan City
      • Aswan, New Aswan City, Egypt, 81528
        • Aswan University-Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patient group
Patients were treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum homocysteine were 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effect of oral isotretinoin on Serum homocysteine in acne vulgaris patients
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 3, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 322/1/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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