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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Isotretinoin

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soher Ali, Lecturer; Phone Number: +201066877343; Email: soher.abdel-hamid@med.svu.edu.eg
• Study Contact Backup: Name: Hassan Ibrahim, Assist.Prof; Phone Number: +201011524245; Email: hassan.mohamed@med.svu.edu.eg

Study Locations

• Egypt
  • Qinā, Egypt
    • Qena Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pateints with Moderate Acne; 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.	Drug: Isotretinoin; 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 .; Other Names: irisin
Active Comparator: Pateints with Severe Acne; 20 patients affected by Acne and Entire face is involved, covered with many papules and pustules, open or closed comedones and rare nodules	Drug: Isotretinoin; 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 .; Other Names: irisin
Active Comparator: control; 20 Health participants	Drug: Isotretinoin; 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 .; Other Names: irisin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From 0 base to 3 Months from starting the treatment Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evalaute the effect of treatment with systemic isotretinon	Evalaute the effect of treatment with systemic isotretinon on the level of serum irisin .	From 0 base to 3 Months from starting the treatment Day

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Principal Investigator: Essra Abass, Lecturer, Clinical Pathology Department, Faculty of Medicine, South valley University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 15, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Dermatologic Agents; Isotretinoin
• Other Study ID Numbers: Nahed Abouelwfa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No