Papule-pustular rosacea
Conditions
Interventions
All participants will perform the following previous laboratory tests to assess the inclusion and exclusion criteria: blood count, total cholesterol and fractions, triglycerides, fasting blood glucose
Drug
D02.455.326.271.665.202.495.325
Sponsors
Universidade Federal De São Paulo - UNIFESP
Universidade Federal De São Paulo - UNIFESP
Eligibility
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: Signature of the Free and Informed Consent Form (ICF) and Authorization Form for Photography before any study procedure; men or women aged between 20 and 75 years old, in good health; clinical diagnosis of papular pustular rosacea, with or without ocular involvement, with or without the presence of phyma, and who have been in the active phase of the disease for at least 1 month before the date of inclusion; participants must present on the day of inclusion at least 6 active lesions on the face (papules or pustules), that is, a score greater than or equal to 3 of the static score of 8 points for global assessment of rosacea by the investigator (Investigator's Global Assessment of Rosacea: 8 Point Static Score); absence of topical or systemic treatment, except sunscreens, for at least 3 months; absence of antibiotic therapy (cyclins, macrolides, metronidazole, azalides), for any reason, for at least 3 months; absence of previous treatment with oral isotretinoin or other systemic retinoid; absence of chemotherapy in the last 3 months; absence of a history of hypersensitivity to the study drugs; absence of infectious or other inflammatory dermatoses on the face; absence of clinical evidence or personal history of immunosuppression; absence of habit of drinking alcoholic beverages; absence of photodermatosis; absence of a previous or current history of collagen diseases; agreement to avoid sun exposure throughout the study and agreement with the conditions of the study, ability to understand and strictly follow the guidelines received and availability to attend periodic reevaluations.
Exclusion criteria
Exclusion criteria: Men and women who do not agree with the conditions of the study or without the ability to understand and strictly follow the guidelines received, without availability to attend periodic reevaluations or who refuse to sign the ICF; pregnant or lactating women; women of childbearing age and with sexual activity who refuse to use any method of contraception, such as oral, implantable, injectable or intrauterine contraceptives, introduced at least 120 days after the start of treatment; participant with exclusively phymatous rosacea (type 4); report of abuse of alcoholic beverages and / or illicit drugs; topical or systemic treatment, except sunscreens, for less than 3 months; use of antibiotic therapy (cyclins, macrolides, metronidazole, azalides), for any reason, for at least 3 months; previous treatment with oral isotretinoin; history of non-adherence to previous clinical treatments; previous or current history of collagen diseases; clinical evidence or history of immunodeficiency; use of any immunosuppressive and, or immunomodulatory medication in the last 3 months, topical or systemic; chemotherapy in the last 3 months; history of inflammatory bowel disease or regional enteritis and / or similar symptoms and any clinical observation made by the investigator that prevents participation in the study; presence of significant hepatic laboratory alterations, that is, values of transaminases 2 times above the upper limit of normality; diabetic patients, with fasting blood glucose values above 110mg / dl; presence of significant lipid changes (triglycerides above 300 mg / dl; total cholesterol above 250 mg / dl); presence of leukopenia (leukocytes under 3000 / mm3); history of hypersensitivity to isotretinoin and parabens or doxycycline hydrochloride; previous history of hypervitaminosis A; previous history of bone and or muscle changes and patients in use or who may need the following medications, for systemic use, due to the risk of interaction with the study drug: vitamin A or vitamin complexes with vitamin A up to 30 days ago; carbamazepine up to 7 days ago and cyclin class antibiotics up to 30 days ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 It is expected to find that oral Isotretinoin is a therapeutic option with similar or superior effect to doxycycline in the treatment of moderate to severe cutaneous and ocular rosacea. The evaluation of the effectiveness of the treatment will be made by comparing the following methods, throughout all visits: Opinion of research participants This assessment will follow a 6-point scale (for skin and eyes): 1-much worse; 2 - worse; 3- unchanged; 4- better; 5- much better; 6- total regression of injuries Principal investigator assessment based on the 8-point static score for global rosacea assessment by the investigator (Investigator’s Global Assessment of Rosacea: 8 Point Static Score) Principal investigator assessment based on Rosacea Clinical Scorecard (Wilkin 2004) Blind opinion of 2 independent observers, dermatologists, based on the comparison of pre- and post-treatment photographs, according to the Global Assessment of Rosacea Subtypes (Wilkin 2004) Ophthalmologist's opinion based on the comparison of pre and post treatment eye exams according to the following classification 0: absence of ocular involvement; 1 (mild): signs and symptoms affecting the margin of the eyes and / or the Meibomius glands; 2 (moderate): signs and symptoms affecting the inner region of the eyelids, fluid secretion or the ocular surface; 3 (severe): presence of corneal injury with potential risk of loss of vision (Wilkin 2004) Assessment of the following ophthalmic signs and symptoms: Tearing, bulbar or eyelid conjunctiva, presence of telangiectasias in the conjunctiva or palpebral margin, periocular erythema, presence of hordeolus, foreign body sensation, feeling of sand in the eyes, burning, itching, dryness ocular, sensitivity to light, blurred vision. For each of them, a 4-point scale will be applied: 1- absence of the sign or symptom; 2- light; 3- moderate; 4- severe ;Expected outcome 2 It is expected to find that Oral isotretinoin is safe and well tolerated for | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3 It is expected to find that Oral isotretinoin improves the quality of life of the study participants through the application of the questionnaire on the quality of life index in Dermatology - Dermatology Life Quality Index or DLQI (Finlay, 1994), before and at the end of treatments, already validated for Brazil - DLQI-BR (Ferraz, 2006) ;Expected outcome 4 It is expected to find that Isotretinoin is able to alter the expression of cutaneous markers of rosacea through the evaluation of histological and immunohistochemical changes in a skin fragment obtained by biopsy with a 3 mm punch in a standardized area in the region close to the nasal wing, in the alar sulcus, before and at the end of the treatment. For immunohistochemistry, the following markers will be used: VEGF, CD 31, TLR-2, Catelicidins, TRPV-1 and iNOS;Expected outcome 5 It is expected to find that Isotretinoin is capable of providing longer periods of disease remission than doxycycline through the follow-up of study participants for a further 6 months after the end of treatment, for the assessment of recurrences of rosacea | — |
Countries
Brazil
Contacts
Public ContactFabíola Picosse
Universidade Federal De São Paulo - UNIFESP
Outcome results
None listed