Clinical trial: Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea (NCT03263273)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects who had provided written informed consent to participate in the study.

          -  Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of moderate to
             severe facial rosacea, defined as the presence of: i. At least twelve and not more
             than forty inflammatory facial lesions (i.e., papules/pustules), AND ii. Subjects with
             a grade 3 or 4 on the 5-point Investigators Global Assessment (IGA) scale, AND iii.
             Persistent facial erythema (scored as at least mild on Erythema Severity Scale), AND
             iv. Facial telangiectasia (scored as at least mild on Telangiectasia Severity Scale.

          -  Subject willing to minimize external factors that might trigger rosacea flare-ups as
             recommended per protocol and patient instructional guide (e.g., spicy foods, thermally
             hot foods and drinks, hot environments, prolonged sun exposure, strong winds and
             alcoholic beverages).

          -  Non-nursing, female subjects of child bearing potential, who are using an acceptable
             form of birth control: total abstinence, oral (birth control pills), intravaginal:
             (e.g. NuvaRing®), implantable (e.g. Norplant®), injectable (e.g. Depo-Provera®) or
             transdermal (e.g. Ortho Evra®) contraception; intrauterine device (IUD);
             double-barrier (diaphragm or condom with spermicidal gel or foam); for two months
             prior to study enrollment or a vasectomized partner. All female subjects of child
             bearing potential must have undergone an in-office urine pregnancy test, with a
             negative result, prior to being randomized to receive study drug. In addition, women
             of childbearing potential must have agreed to a have urine pregnancy test at Day 42
             and at the end of the study (Day 84). Females not of childbearing potential due to
             menopause must have been postmenopausal for at least one year. Male subjects must be
             willing to not attempt to conceive a child during the participation in the study.
             Females utilizing oral contraception must be willing to utilize an appropriate
             secondary form of contraception during the study.

          -  Subjects who use the same brand of soap, make-up, hair products, or shaving
             lotion/foam/cream/gel for a period of at least four weeks prior to the Baseline Visit
             and agree not to change these product brand/types during the study, with the exception
             of using the study approved cleanser and moisturizer with sunscreen provided by the
             sponsor.

          -  Male subjects who are willing to shave, if applicable, at approximately the same time
             every day.

          -  Subjects who are willing to refrain from sunbathing, using sun tanning booths/beds, or
             excessive exposure to the sun for the duration of the study.

        Exclusion Criteria:

          -  Presence of any skin condition on the face that would interfere with the diagnosis or
             assessment of rosacea as determined by the Investigator.

          -  Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere
             with diagnosis or assessment of rosacea. Patients also must not grow excess facial
             hair during the study (i.e. they need to be free of excess facial hair for follow-up
             visits).

          -  History of hypersensitivity or allergy to minocycline, any other tetracycline or any
             other component of the formulation, or known reactions to cleansers, including Ponds
             Cold Cream, and moisturizer with sunscreen.

          -  Subjects using, or planning use of concomitant treatments within 30 days prior to
             Baseline visit (e.g., facial or chemical peels, dermal fillers, acne surgery,
             intralesional steroids, spironolactone, debridement, cryotherapy, dermabrasion, X-ray,
             IPL, laser therapy or UV therapy).

          -  Use within 6 months prior to baseline of oral retinoids (e.g. isotretinoin, acitretin)
             or therapeutic vitamin A supplements of greater than 10,000 International Units/day
             (multivitamins are allowed).

          -  Subjects using estrogens or progestin agents (e.g., Gynogen, Valergen, Depo-Testadiol,
             Depogen, birth control pills), for less than 2 months prior to the Baseline Visit.
             (Subjects using estrogens for 2 months or more are not excluded unless the subject
             expected to change dose, drug, or discontinue estrogen use during the study).

          -  Use within 2 month prior to the Baseline Visit of 1) topical retinoids to the face, 2)
             systemic antibiotics known to have an impact on the severity of facial rosacea (e.g.,
             containing tetracycline and its derivatives, erythromycin and its derivatives,
             sulfamethoxazole, or trimethoprim, metronidazole), or 3) systemic corticosteroids.

          -  Use within 2 months prior to the Baseline Visit of 1) topical corticosteroids, 2)
             topical antibiotics or 3) topical medications for rosacea (e.g., metronidazole,
             azelaic acid, erythromycin, ivermectin, sulfur based topical products).

          -  Subjects with rhinophyma, dense telangiectasia, or plaque-like facial edema, more than
             5 nodules or sinus tracts.

          -  Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient
             severity to require topical or systemic antibiotics.

          -  Subjects with underlying diseases or other dermatological conditions, such as; atopic
             dermatitis, perioral dermatitis, or seborrheic dermatitis, which required the use of
             interfering topical or systemic therapy or may have interfered with the rosacea
             diagnosis.

          -  Subjects using an investigational drug or participating in an investigational study
             within 30 days of the Baseline Visit. Use of an investigational drug and/or
             participation in another investigational study prohibited during this study.

          -  Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol
             or drug abuse with in the past year.

          -  Medical history of immunodeficiency or other significant ongoing medical condition or
             disease as determined by the investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? Entailment