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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05529888
Other study ID # 322/1/19
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 15, 2020
Est. completion date December 15, 2021

Study information

Verified date September 2022
Source Aswan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 15, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Aswan University-Faculty of Medicine Aswan New Aswan City

Sponsors (1)

Lead Sponsor Collaborator
Aswan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
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