Efficacy of Extended-Release 45 mg Oral Minocycline and Extended-Release 45 mg Oral Minocycline Plus 15% Azelaic Acid in the Treatment of Acne Rosacea

March 2013 | Volume 12 | Issue 3 | Original Article | 292 | Copyright © March 2013


J. Mark Jackson MD,a Douglas J. Lorenz PhD,b and Leon H. Kircik MDc-e

aDivision of Dermatology, bDepartment of Bioinformatics and Biostatistics, University of Louisville, Louisville, KY cMount Sinai Medical Center, New York, NY dIndiana University School of Medicine, Indianapolis, IN ePhysicians Skin Care, PLLC, Louisville, KY

METHODS

Study Design

This was a randomized, double-blind study of ER minocycline 45 mg and ER minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea. The study consisted of 12 weeks of treatment plus a 4-week follow-up period (total of 16 weeks). Sixty patients were enrolled at 2 investigational centers (n=30 at each center) and completed the 12 weeks of double-blind treatment with a 4-week follow-up. Patients were randomized to receive ER 45 mg minocycline administered as a once-daily oral dose, or ER 45 mg minocycline as a once-daily oral dose plus azelaic acid 15% once daily via topical application each night.

Study Drug

The following medications will be used in this study:
  • Group 1: Once-daily 45 mg oral minocycline as monotherapy.
  • Group 2: Once-daily 45 mg oral minocycline plus topical 15% azelaic acid administered once daily at bedtime.

    • Patient Selection

    Inclusion Criteria
    1. Postpubescent male and females, aged 18 years or older, with rosacea, 10 to 40 papules and pustules and ≤2 nodules.
    2. A score of 2 to 4 on the Investigator’s Global Assessment (IGA) Scale (a 0 to 5 scale where 0 = clear, no evidence of facial lesions; 3 = moderate, papules and pustules are a predominant feature (nodules may be present), and some perilesional erythema should be present, and 5 = very severe, numerous papules and pustules present, nodules may be present, and perilesional erythema is a hallmark of this patient.)
    3. A score of ≥2 on the Clinical Erythema Assessment (CEA) Scale (a 0 to 4 scale where 0 = none, no redness present; 1 = mild, slight pinkness; 2 = moderate, definite redness; 3 = significant, marked erythema, and 4 = severe, fiery redness.)
    4. Female patients of childbearing potential, defined as having an intact uterus and ovaries, older than 50 years, and had menses within the last 12 months, must utilize 2 of the following methods of birth control throughout the study: intrauterine device, diaphragm, a condom plus the use of a spermicidal gel or foam, oral contraceptives (provided patient has been utilizing this method for at least 4 months before baseline and has not changed the brand within this period), or sign an agreement that they will abstain from sexual intercourse during the course of the study. Bilateral tubal ligation or lack of menses for patients younger than 50 years are considered to be of childbearing potential.
    5. Informed consent must be obtained from each subject, and a copy of singed consent was provided to subject.
    6. Negative urine pregnancy test and nonlactating.
    Exclusion Criteria
    1. 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.
    2. The use of systemic antibiotics within 4 weeks of baseline.
    3. The use of a systemic investigational drug within 30 days of baseline and an investigational topical drug within 14 days of baseline.
    4. Pregnant women or women of childbearing potential who are not using an adequate form of birth control as described in the inclusion criteria.
    5. Patients with a known hypersensitivity to tetracyclines.
    6. Patients on clinically significant, concomitant drug therapy.(See Concomitant Medications below.)
    7. The use of any rosacea treatment (over-the-counter or prescription) during the course of the study.
    8. The use of facial topical steroids 4 weeks before baseline and during the study.
    9. The use of systemic corticosteroids 6 weeks before baseline and during the study.
    10. Patients who have had gastric bypass surgery or are considered achlorhydric.
    11. Patients who are diagnosed with diseases with known photosensitivity (eg, porphyria, vitiligo, polymorphic light eruption, actinic prurigo, solar urticaria).
    12. Patients taking drugs that are known photosensitizers (eg, phenothiazines, amiodarone, quinine, thiazides, sulfonamides, quinolones).
    13. The use of a tanning bed.
    Concomitant Medications
    The following medications were prohibited:
    1. The use of tetracycline family antibiotics at any dose is prohibited.
    2. Use of any acne or rosacea treatments during the course of the study, including spironolactone.
    3. Antacids and vitamins containing aluminum, calcium, or magnesium may impair drug absorption and should be taken at least 1.5 hours before or 3.0 hours after taking study medication.
    4. Use of proton pump inhibitors.
    5. Use of phenothiazines.
    6. Use of amiodarone.
    7. Use of thiazides.
    8. Products containing iron should be taken at least 1.5 hours before or at least 3.0 hours after taking the study medication.
    Study Methods
    A complete medical history, lesion score (total number of papules, pustules, and nodules), and the IGA score and CEA score was performed by the investigator for all patients. Urine pregnancy testing was conducted on all women of childbearing potential.
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