Correlation Between Depression Scores and Serum NF-ĸB/NLRP3 Axis, Biotinidase, and HMGB After Treatment With Isotretinoin in Patients With Acne Vulgaris

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: ISOtretinoin 20 MG

• Registration Number: NCT06242288
• Lead Sponsor: Mostafa Bahaa

Brief Summary

Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinization, inflammation, and bacterial colonization of hair follicles on the face, neck, chest, and back by, Cutibacterium acnes. Although all age groups can be affected, it is primarily a disease of adolescence. Treatment selection is based on disease severity, patient preference, and tolerability. Isotretinoin is drug of chioce used for moderate and severe acne. Isotretinoin results in a significant reduction in sebum production, influences comedogenesis, lowers surface and ductal c. acnes and has anti-inflammatory properties. Biotin deficiency may be caused by insufficient dietary uptake of biotin, drug- vitamin interactions and increased biotin catabolism during pregnancy and in smokers. Biotin deficiency can also be precipitated by decreased activities of biotinidase, which plays a central role in the intestinal absorption of biotin

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-27
• Study First Submitted QC: 2024-01-27
• Study Start: 2024-01-30
• Study First Posted: 2024-02-05
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Age of 19 to 35 years. Body mass index (BMI) of 18.5 to 23 kg/m2. Acne vulgaris (global acne scoring more than 18)

Exclusion Criteria

Use of oral steroids, oral contraceptives, oral vitamin A derivatives, antibiotics, or herbal medicines that may affect the test results during the last 4 weeks.

Alcohol drinking within the last week. Smoking. Pregnancy or lactation. Judgement that physical or mental testing is not appropriate for the clinical trial.

Participation in other clinical trials that may affect this t

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparative group	ISOtretinoin 20 MG	20 acne patients taking isotretinoin 20 mg once daily

Primary Outcome Measures

Name	Time	Method
change in biotinidase level	2 months	change in biotinidase level

Trial Locations

Locations (1)

Tanta Unuversity; 🇪🇬 Tanta, Egypt