Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- South Valley University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- serum level of TWEAK
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 10 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: Isotretinoin (Drug)
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
Intervention: ELISA Assays of Serum TWEAK. (Diagnostic Test)
Control group
60 age-sex-matched healthy subjects as a control group
Intervention: ELISA Assays of Serum TWEAK. (Diagnostic Test)
Outcomes
Primary Outcomes
serum level of TWEAK
Time Frame: 12 weeks
To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.
Secondary Outcomes
- evaluate the effect of systemic isotretinoin on serum TWEAK level(12 weeks)
Investigators
Hassan Mohammed Ibrahim
Associate professor
South Valley University