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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-09-30

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.

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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

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Isotretinoin group

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

Group Type ACTIVE_COMPARATOR

Isotretinoin

Intervention Type 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

Control group

Assessment of serum YKL40 in healthy individuals

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes