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

NCT05529888 | Completed Phase 4 DMC

• 1 other identifier: 322/1/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect of oral isotretinoin on Serum homocysteine in acne vulgaris patients

  Assessment in serum level homocysteine level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum homocysteine and effect of isotretinoin therapy on it.

  3 months

Study Arms (2)

Patient group

ACTIVE COMPARATOR

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

Drug: Isotretinoin

Control group

NO INTERVENTION

Assessment of serum YKL40 in healthy individuals

Interventions

Isotretinoin 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

Patient group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of both sexes with acne vulgaris

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University-Faculty of Medicine

Aswān, New Aswan City, 81528, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: group of patients and group of control

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 7, 2022
• Study Start: December 15, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)