Clinical trial: Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea (NCT00823901)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects 18 years of age and older.

          2. Clinical diagnosis of papulopustular facial rosacea.

          3. A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus
             pustules).

          4. Willing and able to understand and sign informed consent.

          5. Able to complete study and comply with study procedures.

        Exclusion Criteria:

          1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),
             or severe acne requiring systemic treatment.

          2. History or presence of regional enteritis or inflammatory bowel disease (e.g.,
             ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of
             antibiotic-associated colitis, bloody diarrhea) or similar symptoms.

          3. Use of topical rosacea treatments in the past 2 weeks.

          4. Use of systemic antibiotics in the past 4 weeks.

          5. Use of systemic retinoids within the past 3 months.

          6. Use of laser or light based rosacea treatments within the past 2 months.

          7. Concomitant use of medications that are reported to exacerbate rosacea, such as
             topical and systemic steroids as these may impact assessments.

          8. Current drug or alcohol abuse.

          9. Other dermatologic conditions that require the use of interfering topical or systemic
             therapy or that might interfere with study assessments such as, but not limited to,
             atopic dermatitis, perioral dermatitis or acne vulgaris.

         10. Clinically significant abnormal findings or conditions (other than rosacea), which
             might, in the opinion of the Investigator, interfere with study evaluations or pose a
             risk to subject safety during the study.

         11. Subjects who are pregnant or planning a pregnancy.

         12. Use of any investigational therapy within the past 4 weeks.

         13. Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
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