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Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients

Primary Purpose

Acne Vulgaris

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cases with moderate and severe acne. Clinical diagnosis of acne Disease Patient not receive any treatment for acne vulgaris at least six months duration. Exclusion Criteria: 1 Pregnant and lactating women. 2. History of chronic liver disease . 3. Cardiovascular disorders . 4. Renal disease . 5. Hyperlipidemia . 6. Depression or mental illness. 7. Insulin dependent diabetes 8 Thyroid disease. 9 Osteoporosis or low bone mineral density . 10 Intestinal disorders such as inflammatory bowel disease or ulcerative colitis

Sites / Locations

  • Qena Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pateints with Moderate Acne

Pateints with Severe Acne

control

Arm Description

20 patients affected by Acne and More than half of the face is involved. Many papules and pustules, many open or closed comedones. One nodule may be present.

20 patients affected by Acne and Entire face is involved, covered with many papules and pustules, open or closed comedones and rare nodules

20 Health participants

Outcomes

Primary Outcome Measures

Evalaute serum level of irisin in acne patient
Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)

Secondary Outcome Measures

Evalaute the effect of treatment with systemic isotretinon
Evalaute the effect of treatment with systemic isotretinon on the level of serum irisin .

Full Information

First Posted
May 10, 2023
Last Updated
May 23, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05869188
Brief Title
Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients
Official Title
Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acne vulgaris is a chronic inflammatory skin disease affecting the pilosebaceous unit. It is clinically characterized by comedones, papules, pustules, nodules, cysts and scarring on the face and trunk. The severity of the disease ranges from mild comedonal acne to severe nodulocystic acne which can be permanently disfiguring.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.In addition to the physical lesions, the disease can have a profound psychologic impact, contributing to low self-esteem, depression and anxiety.
Detailed Description
The prevalence of self-reported acne and clinically confirmed acne was 34.69% and 24.39%, respectively. Females reported acne more frequently than males did (39.13% ).The prevalence of clinically confirmed acne was higher among females (28.64%) than males . Its pathogenesis results from androgen-induced increased sebum production, altered keratinization, inflammation of infundibular epithelium and bacterial colonisation of hair follicles by Propionibacterium acne There are several treatment modalities for acne vulgaris including topical like topical antibiotics, topical benzoyl peroxide, topical azelaic acid and topical retinoids. Systemic therapy like antibiotics, hormonal therapy and isotretinoin . Adipokines may have a role in the pathogenesis of acne vulgaris and are associated with acne severity. Irisin, a hormone -like myokine, is one of the adipokines with anti- inflammatory and anti-oxidant effects There is limited evidence for physical modalities (e.g., laser therapy, light therapy, chemical peels) and complementary therapies (e.g., purified bee venom, low-glycemic-load diet, tea tree oil) . isotretinoin (13-cis retinoic acid) is the most potent known inhibitor of sebum production. The multiple modes of action for isotretinoin includs suppression of sebaceous gland activity, normalization of the pattern of keratinization within the sebaceous gland follicle, inhibition of inflammation and reduction of growth of Propionibacterium acne .

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pateints with Moderate Acne
Arm Type
Active Comparator
Arm Description
20 patients affected by Acne and More than half of the face is involved. Many papules and pustules, many open or closed comedones. One nodule may be present.
Arm Title
Pateints with Severe Acne
Arm Type
Active Comparator
Arm Description
20 patients affected by Acne and Entire face is involved, covered with many papules and pustules, open or closed comedones and rare nodules
Arm Title
control
Arm Type
Active Comparator
Arm Description
20 Health participants
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Other Intervention Name(s)
irisin
Intervention Description
Evaluate serum irisin level in acne vulgaris and compare it with healthy control . Evaluate the effect of systemic isotretinoin on serum irisin in acne vulgaris patients .
Primary Outcome Measure Information:
Title
Evalaute serum level of irisin in acne patient
Description
Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)
Time Frame
From 0 base to 3 Months from starting the treatment Day
Secondary Outcome Measure Information:
Title
Evalaute the effect of treatment with systemic isotretinon
Description
Evalaute the effect of treatment with systemic isotretinon on the level of serum irisin .
Time Frame
From 0 base to 3 Months from starting the treatment Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cases with moderate and severe acne. Clinical diagnosis of acne Disease Patient not receive any treatment for acne vulgaris at least six months duration. Exclusion Criteria: 1 Pregnant and lactating women. 2. History of chronic liver disease . 3. Cardiovascular disorders . 4. Renal disease . 5. Hyperlipidemia . 6. Depression or mental illness. 7. Insulin dependent diabetes 8 Thyroid disease. 9 Osteoporosis or low bone mineral density . 10 Intestinal disorders such as inflammatory bowel disease or ulcerative colitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soher Ali, Lecturer
Phone
+201066877343
Email
soher.abdel-hamid@med.svu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan Ibrahim, Assist.Prof
Phone
+201011524245
Email
hassan.mohamed@med.svu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essra Abass, Lecturer
Organizational Affiliation
Clinical Pathology Department, Faculty of Medicine, South valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qena Hospital
City
Qinā
Country
Egypt

12. IPD Sharing Statement

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Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients

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