Clinical trial NCT05869188: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: Evalaute serum level of irisin in acne patient
timeFrame: From 0 base to 3 Months from starting the treatment Day
Secondary outcomes:
measure: Evalaute the effect of treatment with systemic isotretinon
timeFrame: From 0 base to 3 Months from starting the treatment Day
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Hospital
Study officials:
affiliation: Clinical Pathology Department, Faculty of Medicine, South valley University
name: Essra Abass, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: