Clinical study to evaluate efficacy, safety and disease-free time with low-dose Oral Isotretinoin compared to Doxycycline in the treatment of papule pustular Rosacea

Phase 4

• Conditions: Papule-pustular rosacea; C17.800.716

• Registration Number: RBR-4f9cdj
• Lead Sponsor: niversidade Federal De São Paulo - UNIFESP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified