Serum TWEAK Levels in Acne Vulgaris

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

Detailed Description
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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.

Official Title
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Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Isotretinoin
* Diagnostic Test: ELISA Assays of Serum TWEAK.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I patients<br>90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases | Drug: Isotretinoin<br>* systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months<br>Diagnostic Test: ELISA Assays of Serum TWEAK.<br>* : 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<br>|
| Active Comparator: Control group<br>60 age-sex-matched healthy subjects as a control group | Diagnostic Test: ELISA Assays of Serum TWEAK.<br>* : 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<br>|

What is the study measuring?
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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 |