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

Phase 4

Active, not recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: Isotretinoin

• Registration Number: NCT05218486
• Lead Sponsor: Alshimaa Abbas Mohamed Ebrahim

Brief Summary

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

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 YKL-40 level in acne patient before and after oral isotretinoin treatment

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isotretinoin group	Isotretinoin	Patients will be treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum YKL40 will be assessed before and after treatment

Primary Outcome Measures

Name	Time	Method
Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.	3 months	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.

Trial Locations

Locations (1)

Aswan university; 🇪🇬 Aswan, Egypt