acne
Conditions
Interventions
Randomization, through a computer-obtained list, for two treatment groups: 20 women azelaic acid 15% gel twice a day and 20 women oral spironolactone, 100mg/day.
First visit activities: biographic da
HP3.106
Sponsors
Universidade Federal de São Paulo
Leo Pharma Ltda
Eligibility
Sex/Gender
Female
Age
25 Years to 44 Years
Inclusion criteria
Inclusion criteria: Women aged between 25 and 44yo; presence of moderate facial acne (11 to 20 lesions); with or without scarring and sequels of hyperpigmentation; with no other signs or symptoms of hyperandrogenism; after informed consent and photographic consent signature.
Exclusion criteria
Exclusion criteria: pregnant or lactating; light or severe acne; treatment of acne with oral cyclin group antibiotics (previous three months); oral isotretinoin (previous six months); topical products (previous three months, except cleansers, moisturizer and sunscreen); oral spironolactone at any time; combined oral contraceptive started in the last 6 months; other drugs: cortisone, lithium, anticonvulsants, isoniazid, androgens, danazol, iodides, bromides, disulphide, cyclosporine, azathioprine, thiourea, vitamins B2, B6 and B12; contraindications to the treatment options - for spironolactone: use of aldosterone antagonist (amiloride or eplerenone); renal insufficiency; hyperkalaemia; Addison’s disease; significant low blood pressure; hypersensivity to spironolactone; for AA: previous allergic or irritative symptoms to AA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase of serum levels of IL-10 and decrease of IL-17, as well as their quantitative skin expression evaluated by immunohistochemistry and digital analysis in inflammatory lesion and perilesional area. Similar expression in perilesional and inflammatory area will corroborate to the hypothesis that inflammation occurs prior to the development of clinical lesions. The treatment modulation of IL-10 and IL-17 will be considered as success. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement or complete clearance (this will be difficult as patients will receive monotherapy) of skin lesions and overall appearance of skin, through count of inflammatory lesions by the investigaror (on a 4-point scale: 0 = complete improvement, 1 = partial improvement, 2 = unchanged, 3 = worsening); general appearance of the skin by the investigator, the research participants and two independent observers, and photographic evaluation. ;Increasing Acne-QoL-BR scores by re-applying the questionnaire after treatment will be considered a success (total score ranges from 0 to 114 and higher scores reflect better health-related quality of life).;Demonstration of the possible correlation between acne and metabolic syndrome, measurement of abdominal circumference, blood pressure, weight, height and body mass index -BMI, and laboratory tests (glucose, blood cell count, cholesterol and fractions, triglycerides, ALT, AST, alkaline phosphatase, gamma glutamyl transferase, urea, creatinine, insulin, HOMA-IR). | — |
Countries
Brazil
Contacts
Public ContactMaria Santos
Outcome results
None listed