Patients with moderate to severe, papulopustular rosacea. MedDRA version: 12.1 Level: LLT Classification code 10039218 Term: Rosacea
Conditions
Interventions
Trade Name: Efracea, capsules met gereguleerde afgifte, hard 40 mg
Product Name: doxycycline (Efracea)
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DOXYCYCLINE
CAS Number: 564-25-0
Concentr
Sponsors
Academical medical Center, Department of dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is 18 years of age or older at baseline; both genders. 2. Subject has moderate to severe papulopustular rosacea, characterised by at least 8 lesions (papules and/or pustules), IGA higher than two and a CEA score higher than one, clinical confirmed by one of the investigators. 3. Subject has a negative urine pregnancy test at screening and uses a form of anticonception. 4. Subject can fill out a Dutch questionnaire or has a person willing to translate the questions in their own language. 5. Subject has voluntarily signed and dated an informed consent prior to any study related procedure and is willing to comply with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject is pregnant, nursing, or planning pregnancy while enrolled in the study and until 3 months after discontinuation of the study. 2. Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results. 3. The initiation of a hormonal method of contraception within 3 months of baseline; or discontinuation during the course of study; or change in the actual product within 3 months of baseline or during the study. 4. Known hypersensitivity/allergy to tetracycline’s. 5. Subject has used topical medications/treatments that could affect rosacea evaluation starting within 2 weeks of the first administration of study agent. 6. Subject has used systemic treatments (antibiotics, corticosteroids) for rosacea less than 4 weeks before baseline. 7. Subject has had facial laser-therapy less than 4 weeks before baseline or planned during study. 8. Subject has used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer. 9. Subject has used isotretinoin in the six months prior to randomization. 10. Subject is known to have hepatic impairment or to those receiving potentially hepatotoxic medicinal products. 11. Subjects is known to have, or is suspected to have, achlorhydria (production of gastric acid in the stomach is absent) or had surgery that bypasses or excludes the duodenum. 12. Current drug or alcohol abuse. 13. For any reason, subject is considered by the local investigator to be an unsuitable candidate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of doxycycline 40 mg (Efracea) versus minocycline 100 mg treatment in adult patients with papulopustular rosacea.;Secondary Objective: To evaluate the safety of doxycycline and minocycline treatment in rosacea. The effect of therapy on quality of life.;Primary end point(s): The primary efficacy variables are change in lesion count and the rosacea-specific Quality of life instrument (RosaQoL) at week 16. | — |
Countries
Netherlands
Outcome results
None listed