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OpenTrials
Completed

NCT Number: NCT06242288

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISOtretinoin 20 MG

Drug

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

Primary outcomes

  1. change in biotinidase level

    Time frame: 2 months

    change in biotinidase level

Sponsors and collaborators

Lead sponsor

Mostafa Bahaa

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.