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

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Isotretinoin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pateints with Moderate Acne<br>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<br>* 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 .<br>* Other names: irisin;|
| Active Comparator: Pateints with Severe Acne<br>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<br>* 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 .<br>* Other names: irisin;|
| Active Comparator: control<br>20 Health participants | Drug: Isotretinoin<br>* 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 .<br>* Other names: irisin;|

What is the study measuring?
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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 |