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Completed

NCT Number: NCT05684861

Serum TWEAK Levels in Acne Vulgaris

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

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Key information

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

South Valley University

Qina, Qena Governorate, 83522, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

isotretinoin

Drug

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

ELISA Assays of Serum TWEAK.

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

Primary outcomes

  1. 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

  1. evaluate the effect of systemic isotretinoin on serum TWEAK level

    Time frame: 12 weeks

    the comparison of the serum TWEAK before and after treatment with isotretinoin in moderate and severe cases of acne vulgaris.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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