Clinical trial

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

Name
Nahed Abouelwfa
Description
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.
Trial arms
Trial start
2023-06-01
Estimated PCD
2023-12-15
Trial end
2024-01-01
Status
Not yet recruiting
Treatment
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 .
Arms:
Pateints with Moderate Acne, Pateints with Severe Acne, control
Other names:
irisin
Size
60
Primary endpoint
Evalaute serum level of irisin in acne patient
From 0 base to 3 Months from starting the treatment Day
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-05-24

1 organization

1 product

1 indication

Indication
Acne Vulgaris