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

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

Detailed Description
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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

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Isotretinoin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy persons of both sexes with moderate and severe acne. Age above 14 years. Exclusion Criteria: Pregnant and lactating women, immunocompromised patients. History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease. History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks. Cases with known hypersensitivity reaction to isotretinoin.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isotretinoin group<br>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 | Drug: Isotretinoin<br>* 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<br>|
| No Intervention: Control group<br>Assessment of serum YKL40 in healthy individuals | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |