Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.

NCT ID: NCT05529888

Last Updated: 2022-09-07

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2021-12-15

Brief Summary

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Serum homocysteine level in Acne patients before and after oral Isotretinoin and Correlation between serum level of homocysteine in acne patients before and after Oral isotretinoin treatment

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 homocysteine level in acne patient befor and after oral isotrtinoin treatment

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group of patients and group of control
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Patient group

Patients were treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum homocysteine were 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

* Patients of both sexes with acne vulgaris

Exclusion Criteria

* Patients with history of malignancies.
* Patients with renal and hepatic dysfunction.
* Cardiac patient.
* Pregnant, lactating and female welling to have pregnancy in the period of study.
* Patient with absorption disorder.
* Patient with history of favism.
* Patient has already been treated with isotretinoin.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aswan University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Hamdi Abd Elal Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aswan University-Faculty of Medicine

Aswān, New Aswan City, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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322/1/19

Identifier Type: -

Identifier Source: org_study_id

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