Clinical trial: A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules (NCT03340961)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects must be able to understand the requirements of the study and be willing to
             give written informed consent.

          2. Male and female subjects aged 18 years and above.

          3. Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in
             good general health as determined by the Investigator.

          4. Subjects must have a clinical diagnosis of papulopustular rosacea, IGA grade 2 - 4.

          5. Subjects must have 10 - 40 (both inclusive) inflammatory lesions (papules and
             pustules) of rosacea over the face.

          6. Subjects must have not more than 2 nodules.

          7. Subjects with moderate to severe erythema with a total score of 5 - 20 on the CEA
             scale.

          8. Females must have a negative urine pregnancy test at the screening and baseline visit.

          9. Females must either be postmenopausal with no menses for at least 12 months or
             surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective
             method of contraception with a pearl index of <1% up to 1 month after last dose.

         10. Subjects must be in good general health as determined by the investigator and
             supported by the medical history and normal or not clinically significant abnormal
             vital signs (blood pressure and pulse).

        Exclusion Criteria:

          1. Females who are pregnant or nursing or planning to become pregnant during the study.

          2. Male whose female partner is planning to conceive a child.

          3. Subjects who have been treated for rosacea within the 30 days prior to the Baseline
             Visit (e.g. metronidazole, azelaic acid, doxycycline or brimonidine).

          4. Subjects who have been treated with systemic retinoids within 6 months prior to the
             Baseline visit.

          5. Subjects who have participated in a trial involving any investigational product in the
             90 days prior to the Baseline Visit.

          6. Subjects with any disease or medical condition that would interfere with the study
             outcome or place the subject at undue risk.

          7. Subjects who use or have used systemic steroids within the 30 days prior to the
             Baseline Visit or any other immunosuppressive medication.

          8. Subjects who are on anti-coagulants or those who are likely to require anti-coagulants
             during the study period.

          9. History of drug or alcohol abuse in the last year.
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