Serum TWEAK Levels in Acne Vulgaris

NCT ID: NCT05684861

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-01-01

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Isotretinoin

Intervention Type: DRUG

systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months

ELISA Assays of Serum TWEAK.

Intervention Type: DIAGNOSTIC_TEST

: 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

Control group

60 age-sex-matched healthy subjects as a control group

Group Type: ACTIVE_COMPARATOR

ELISA Assays of Serum TWEAK.

Intervention Type: DIAGNOSTIC_TEST

: 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

Interventions

Isotretinoin

systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months

Intervention Type: DRUG

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Hassan Mohammed Ibrahim

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan M Ibrahim, professor

Role: STUDY_DIRECTOR

South Valley University

Locations

South Valley University

Qina, Qena Governorate, Egypt

Countries

Egypt

Other Identifiers

SVU MED DVA021 4 22 11 508

Identifier Type: -

Identifier Source: org_study_id