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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869188
• Other study ID #: Nahed Abouelwfa
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: South Valley University
• Contact: Soher Ali, Lecturer
• Phone: +201066877343
• Email: soher.abdel-hamid[@]med.svu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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 .

Locations

Country	Name	City	State
Egypt	Qena Hospital	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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