Serum TWEAK Levels in Acne Vulgaris

South Valley University

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Isotretinoin; Diagnostic Test: ELISA Assays of Serum TWEAK.

Study type: Interventional

Funder types: Other

Identifiers

NCT05684861

SVU MED DVA021 4 22 11 508

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Group I patients

Active Comparator group

Description:

90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases

Treatment:

Drug: Isotretinoin

Diagnostic Test: ELISA Assays of Serum TWEAK.

Control group

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: ELISA Assays of Serum TWEAK.