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

A

Alshimaa Abbas Mohamed Ebrahim

Status and phase

Active, not recruiting
Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Isotretinoin

Study type

Interventional

Funder types

Other

Identifiers

NCT05218486
551/7/21

Details and patient eligibility

About

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

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

15 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Isotretinoin group
Active Comparator group
Description:
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
Treatment:
Drug: Isotretinoin
Control group
No Intervention group
Description:
Assessment of serum YKL40 in healthy individuals

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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