Serum TWEAK Levels in Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684861
• Other study ID #: SVU MED DVA021 4 22 11 508
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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

Locations

Country	Name	City	State
Egypt	South Valley University	Qina	Qena

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level of TWEAK	To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.	12 weeks
Secondary	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