Effect of Systemic Isotretinoin on Serum Irisin Level in Acne Vulgaris Patients
- Registration Number
- NCT05869188
- Lead Sponsor
- South Valley University
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Cases with moderate and severe acne.
- Clinical diagnosis of acne Disease
- Patient not receive any treatment for acne vulgaris at least six months duration.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pateints with Moderate Acne Isotretinoin 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. control Isotretinoin 20 Health participants Pateints with Severe Acne Isotretinoin 20 patients affected by Acne and Entire face is involved, covered with many papules and pustules, open or closed comedones and rare nodules
- Primary Outcome Measures
Name Time Method Evalaute serum level of irisin in acne patient From 0 base to 3 Months from starting the treatment Day 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
Name Time Method Evalaute the effect of treatment with systemic isotretinon From 0 base to 3 Months from starting the treatment Day Evalaute the effect of treatment with systemic isotretinon on the level of serum irisin .
Trial Locations
- Locations (1)
Qena Hospital
🇪🇬Qinā, Egypt