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NCT05218486 Clinical Trial

Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients

Acne Vulgaris Clinical Trial

Official title:
Evaluation of The Effect of Oral Isotretinoin on The Level of Serum YKL40 in Acne Vulgaris Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05218486
Other study ID # 551/7/21
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date August 1, 2021
Est. completion date September 30, 2022

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

Clinical Trial Summary

The aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria: 1. Healthy persons of both sexes with moderate and severe acne. 2. Age above 14 years. Exclusion Criteria: 1. Pregnant and lactating women, immunocompromised patients. 2. History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease. 3. History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks. 4. Cases with known hypersensitivity reaction to 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 Aswan

Sponsors (1)
Lead Sponsor Collaborator
Alshimaa Abbas Mohamed Ebrahim

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 months
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