Serum TWEAK Levels in Acne Vulgaris

Sponsor
South Valley University (Other)
Overall Status
Completed
CT.gov ID
NCT05684861
Collaborator
(none)
150
1
2
12
12.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Dec 20, 2022
Actual Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

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

Active Comparator: Control group

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

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

Outcome Measures

Primary Outcome Measures

  1. serum level of TWEAK [12 weeks]

    To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.

Secondary Outcome Measures

  1. evaluate the effect of systemic isotretinoin on serum TWEAK level [12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 60 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 South Valley University Qinā Qena Egypt 83522

Sponsors and Collaborators

  • South Valley University

Investigators

  • Study Director: Hassan M Ibrahim, professor, South Valley University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hassan Mohammed Ibrahim, Associate professor, South Valley University
ClinicalTrials.gov Identifier:
NCT05684861
Other Study ID Numbers:
  • SVU MED DVA021 4 22 11 508
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2023