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

NCT06242288 | Completed Phase 3

• 1 other identifier: 659874
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• change in biotinidase level

  change in biotinidase level

  2 months

Study Arms (2)

control group

NO INTERVENTION

age and sex matched healthy control

Comparative group

ACTIVE COMPARATOR

20 acne patients taking isotretinoin 20 mg once daily

Drug: ISOtretinoin 20 MG

Interventions

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

Comparative group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mostafa Bahaa: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, 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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching assisstant

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 5, 2024
• Study Start: January 30, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

EG (1)