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Completed

NCT Number: NCT05529888

Measure the Serum Level of Homocysteine 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

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Key information

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aswan University-Faculty of Medicine

Aswān, New Aswan City, 81528, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

isotretinoin

Drug

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

Serum Homocysteine Level in Acne Patients Before and After Oral Isotretinoin

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2022
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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