Clinical trial: Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea (NCT03667222)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female subjects ≥18 years of age at the time of consent.

          2. Subjects do not have any medical conditions, other than rosacea, that in the opinion
             of the investigator, put the subject at unacceptable risk or could interfere with
             study assessments or integrity of the data.

          3. A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea
             (papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and
             papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment
             (IGA)

          4. Have 15-70 papulopustular lesions of rosacea on the face with no more than 2 nodules.

          5. Female subjects of childbearing potential are willing to use effective contraceptive
             method (s) for at least 4 weeks before Baseline and at least 4 weeks after the last
             study product administration or have a sterilized or same sex partner for the duration
             of the study. Effective contraceptive methods are: systemic hormonal contraceptives,
             intrauterine device or barrier method of contraception in conjunction with spermicide
             or agree to sexual abstinence. Hormonal contraceptives must be on a stable dose for at
             least 12 weeks before Baseline. Subjects using low dose (≤35 ug ethinyl estradiol)
             oral contraceptives must use a second form of birth control (e.g., barrier method such
             as condoms with spermicide).

          6. Female subjects of childbearing potential must have a negative urine pregnancy test
             (dipstick).

          7. Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or
             sunscreens must have used the same product brands/types for a minimum period of 2
             weeks prior to Baseline, must agree not to change brand/type or frequency of use
             throughout the study and must agree not to use make-up, facial moisturizers, creams,
             lotions, cleansers and/or sunscreens on the scheduled clinic visit days before the
             visit.

          8. Be willing to limit or avoid known personal 'triggers' of rosacea such as spicy foods,
             consumption of alcoholic beverages, extended sun exposure, tanning beds, etc., for the
             duration of the study.

          9. Subjects must be capable of giving informed consent and the written informed consent
             must be obtained prior to any study-related procedures.

        Exclusion Criteria:

          1. Have a history of skin disease, presence of skin condition, scarring or excessive
             facial hair the PI believes would interfere with the study.

          2. Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema.

          3. Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial
             erythrosis other than rosacea.

          4. Have ocular rosacea of a severity that requires systemic treatment.

          5. Have a history of any adverse reaction to minocycline or other tetracycline class
             antibiotic.

          6. Have a clinically significant chemistry or hematology value or have an ALT or AST that
             is greater than or equal to 2x normal.

          7. Have any conditions or factors that the PI believes may affect the response of the
             skin or the interpretation of the results.

          8. Have a history of symptoms that might be confused with a diagnosis of pseudotumor
             cerebri such as severe headaches or visual disturbances inconsistent with a diagnosis
             of migraine or have a history of traumatic brain injury with headache and/or visual
             disturbances.

          9. Have used on the face an over the counter (OTC) topical medication for the treatment
             of rosacea within 4 weeks prior to Baseline.

         10. Have used prescription topical (on the face) and/or oral antibiotics within 4 weeks
             prior to Baseline.

         11. Treatment with hormonal therapy or oral corticosteroids that is not on a stable dose
             and frequency for at least 12 weeks before Baseline and not stable throughout the
             study.

         12. Have had a facial procedure such as chemical peel, laser, microdermabrasion or
             injections with a dermal filler or neuromodulator within 8 weeks prior to Baseline.

         13. Have received photodynamic therapy or phototherapy to the face within 12 weeks prior
             to Baseline.

         14. Have used an oral retinoid within 6 months or a topical retinoid within 3 months prior
             to Baseline.

         15. Current drug or alcohol abuse.

         16. Female subject who is breastfeeding, pregnant or who is planning a pregnancy during
             the study.

         17. Participated in any clinical study with exposure to any investigational treatment or
             product within the previous 4 weeks to Baseline, or plan on concurrent participation
             in other studies.
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