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Serum TWEAK Levels in Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Isotretinoin
ELISA Assays of Serum TWEAK.
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acne Vulgaris

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • South Valley University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I patients

Control group

Arm Description

90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 1, 2023
Last Updated
January 5, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05684861
Brief Title
Serum TWEAK Levels in Acne Vulgaris
Official Title
Serum TWEAK Levels in Acne Vulgaris Patients Treated With Oral Isotretinoin
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I patients
Arm Type
Active Comparator
Arm Description
90 patients with acne vulgaris Patients classified according to the global acne grading system(GAGS) into moderate, severe, and very severe cases
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
60 age-sex-matched healthy subjects as a control group
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Intervention Description
systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months
Intervention Type
Diagnostic Test
Intervention Name(s)
ELISA Assays of Serum TWEAK.
Intervention Description
: 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 Outcome Measure Information:
Title
serum level of TWEAK
Description
To evaluate the serum level of TWEAK in patients with moderate to severe acne vulgaris.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
evaluate the effect of systemic isotretinoin on serum TWEAK level
Description
the comparison of the serum TWEAK before and after treatment with isotretinoin in moderate and severe cases of acne vulgaris.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan M Ibrahim, professor
Organizational Affiliation
South Valley University
Official's Role
Study Director
Facility Information:
Facility Name
South Valley University
City
Qinā
State/Province
Qena
ZIP/Postal Code
83522
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Serum TWEAK Levels in Acne Vulgaris

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