Doxycycline versus minocycline in the treatment of rosacea: a randomised controlled trial.

INTERVENTION: 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 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Trade Name: Minocycline 100 PCH, omhulde tabletten 100 mg Product Name: minocycline Pharmaceutical Form: Tablet CAS Number: 10118‐90‐8 Other descriptive name: MINOCYCLINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: Patients with moderate to severe, papulopustular rosacea. ; MedDRA version: 12.1 Level: LLT Classification code 10039218 Term: Rosacea PRIMARY OUTCOME: Main Objective: To compare the efficacy of doxycycline 40 mg (Efracea) versus minocycline 100 mg treatment in adult patients with papulopustular rosacea. 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. Secondary Objective: To evaluate the safety of doxycycline and minocycline treatment in rosacea.; The effect of therapy on quality of life. 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 (>=6