Serum TWEAK Levels in Acne Vulgaris

Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Isotretinoin; Diagnostic test: ELISA Assays of Serum TWEAK.

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Qena
    • Qinā, Qena, Egypt, 83522
      • South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I patients; 90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases	Drug: Isotretinoin; systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months; Diagnostic test: ELISA Assays of Serum TWEAK.; : From each subject, 5mL of blood was collected into vacutainers before and after treatment with isotretinoin. The blood samples were centrifuged at 3000g for 10 min at a temperature of 4°C, then . Quantitative determinations for serum TWEAK were achieved using the corresponding commercially available ELISA kit supplied by the AssayMax
Active Comparator: Control group; 60 age-sex-matched healthy subjects as a control group	Diagnostic test: ELISA Assays of Serum TWEAK.; : From each subject, 5mL of blood was collected into vacutainers before and after treatment with isotretinoin. The blood samples were centrifuged at 3000g for 10 min at a temperature of 4°C, then . Quantitative determinations for serum TWEAK were achieved using the corresponding commercially available ELISA kit supplied by the AssayMax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum level of TWEAK	To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Study Director: Hassan M Ibrahim, professor, South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Estimate): January 13, 2023

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Isotretinoin
• Other Study ID Numbers: SVU MED DVA021 4 22 11 508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No