Serum TWEAK Levels in Acne Vulgaris

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Isotretinoin; Diagnostic Test: ELISA Assays of Serum TWEAK.

• Registration Number: NCT05684861
• Lead Sponsor: South Valley University

Brief Summary

Evaluate the serum level of TWEAK in patients with AV and their relations before and after treatment with isotretinoin.

Detailed Description

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles, characterized by comedones, papules, pustules, cysts, nodules, and occasionally scars. Its pathogenesis includes follicular hyperkeratinization, sebaceous hypersecretion due to androgen stimulation, follicular colonization by Propionibacterium acnes, immune and inflammatory responses. It affects the face, anterior chest, and upper back . Inflammation is regarded as a key component in the pathogenesis of acne . An increase in the activity of the pro inflammatory cytokine, interleukin (IL) 1, is observed before the beginning of hyperproliferation around the uninvolved follicles and is thought to trigger the activation of keratinocyte proliferation. Nuclear factor kappa beta (NF κβ) regulated mRNA gene levels of the cytokines tumour necrosis factor (TNF) α, IL 1 β, IL 8 and IL 10 levels also affected.

Isotretinoin (13-cis retinoic acid) is a synthetic analog of vitamin A. Its oral form is prescribed for severe cases which are resistant to other treatments.

Tumor necrosis factor (TNF)-like weak inducer of apoptosis (TWEAK) belongs to the TNF superfamily. It has an important role in the regulation of cell growth, apoptosis, angiogenesis, and immune reactions.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-20
• Status Verified: 2023-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-13
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases

Exclusion Criteria

• Pregnant and lactating women, patients with renal, GIT, skeletal, psychiatric, and endocrine disorders, sarcoidosis, and patients receiving drugs such as diuretics, multivitamins, anticonvulsants, glucocorticoids, erythromycin, estrogen compound pill were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group I patients	ELISA Assays of Serum TWEAK.	90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases
Control group	ELISA Assays of Serum TWEAK.	60 age-sex-matched healthy subjects as a control group
Group I patients	Isotretinoin	90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases

Primary Outcome Measures

Name	Time	Method
serum level of TWEAK	12 weeks	To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.

Secondary Outcome Measures

Name	Time	Method
evaluate the effect of systemic isotretinoin on serum TWEAK level	12 weeks	the comparison of the serum TWEAK before and after treatment with isotretinoin in moderate and severe cases of acne vulgaris.

Trial Locations

Locations (1)

South Valley University; 🇪🇬 Qinā, Qena, Egypt