Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Isotretinoin

• Registration Number: NCT05869188
• Lead Sponsor: South Valley University

Brief Summary

Acne vulgaris is a chronic inflammatory skin disease affecting the pilosebaceous unit. It is clinically characterized by comedones, papules, pustules, nodules, cysts and scarring on the face and trunk.
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Detailed Description

The prevalence of self-reported acne and clinically confirmed acne was 34.69% and 24.39%, respectively. Females reported acne more frequently than males did (39.13% ).The prevalence of clinically confirmed acne was higher among females (28.64%) than males .
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-22
• Study Start: 2023-06-01
• Primary Completion: 2023-12-15
• Study Completion: 2024-01-01
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Cases with moderate and severe acne.
• Clinical diagnosis of acne Disease
• Patient not receive any treatment for acne vulgaris at least six months duration.

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Exclusion Criteria

1 Pregnant and lactating women. 2. History of chronic liver disease . 3. Cardiovascular disorders . 4. Renal disease . 5. Hyperlipidemia . 6. Depression or mental illness. 7. Insulin dependent diabetes 8 Thyroid disease. 9 Osteoporosis or low bone mineral density . 10 Intestinal disorders such as inflammatory bowel disease or ulcerative colitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pateints with Moderate Acne	Isotretinoin	20 patients affected by Acne and More than half of the face is involved. Many papules and pustules, many open or closed comedones. One nodule may be present.
control	Isotretinoin	20 Health participants
Pateints with Severe Acne	Isotretinoin	20 patients affected by Acne and Entire face is involved, covered with many papules and pustules, open or closed comedones and rare nodules

Primary Outcome Measures

Name	Time	Method
Evalaute serum level of irisin in acne patient	From 0 base to 3 Months from starting the treatment Day	Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)

Secondary Outcome Measures

Name	Time	Method
Evalaute the effect of treatment with systemic isotretinon	From 0 base to 3 Months from starting the treatment Day	Evalaute the effect of treatment with systemic isotretinon on the level of serum irisin .

Trial Locations

Locations (1)

Qena Hospital; 🇪🇬 Qinā, Egypt