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van CCT (UK)

van CCT (UK)

Doxycycline vs minocycline in the treatment of rosacea.

- candidate number9058
- NTR NumberNTR2727
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2011
- Secondary IDsMEC 10/174 MEC AMC
- Public TitleDoxycycline vs minocycline in the treatment of rosacea.
- Scientific TitleDoxycycline vs minocycline in the treatment of papulopustular rosacea: A Randomized controlled trial.
- hypothesisWe hypothesize that doxycycline and minocycline will be equally effective for the treatment of papulopustular rosacea.
- Healt Condition(s) or Problem(s) studiedRosacea
- Inclusion criteria1.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 one 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).
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-feb-2011
- planned closingdate19-feb-2013
- Target number of participants80
- Interventions1. Doxycycline 40 mg;
2. Minocycline 100 mg.
These will be given during a period of 16 weeks.
- Primary outcome1. Lesion count;
2. The rosacea-specific Quality of life instrument (RosaQol).
- Secondary outcome1. Patient’s Global Assessment (PaGA);
2. Investigators Global Assessment (IGA);
3. Clinician's Erythema Assessment (CEA);
4. Duration of remission;
5. Safety.
- TimepointsPatients will be seen at screening and at 0, 4,m8 and 16 weeks. The follow up wil be 12 weeks (last visit at week 28).
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Department of Dermatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Dermatology
- PublicationsN/A
- Brief summaryRosacea is a common and chronic dermatosis, mostly occurring in middle aged, fair-skinned men and woman, affecting up to 10% of the general population. Rosacea requires long-term treatment. According to the 2005 Cochrane review, accurate randomized controlled trials (RCT’s) for the treatment of rosacea are lacking. More evidence is needed on systemic treatments that are widely used, including all tetracyclines. Recently, different doses of doxycycline have been studied. Its efficacy has been approved by several studies. And therefore the anti-inflammatory dose of doxycycline 40 mg has officially been accepted as treatment of papulopustualr rosacea. Minocycline, has been used for decades by many patients but no studies to support its effectiveness are available.
- Main changes (audit trail)
- RECORD2-feb-2011 - 14-feb-2011

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