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NCT06242288 Clinical Trial

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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06242288
Other study ID # 659874
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 30, 2024
Est. completion date January 20, 2026

Study information
Verified date February 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 20, 2026
Est. primary completion date January 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• ISOtretinoin 20 MG
Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication primarily used to treat severe acne

Locations
Country Name City State
Egypt Tanta Unuversity Tanta

Sponsors (1)
Lead Sponsor Collaborator
Mostafa Bahaa

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in biotinidase level change in biotinidase level 2 months
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