Clinical trial: Timolol for the Treatment of Acne and Rosacea (NCT02774590)

Eligibility criteria:
Inclusion Criteria:

          -  In the opinion of the investigator, must be medically able to undergo the
             administration of study material

          -  Be able to comprehend the informed consent document and provide consent for
             participation

          -  Females of childbearing potential must:

               -  Not be pregnant by subjective report

               -  agree to not become pregnant or breastfeed for the period of the study through 1
                  month after completion of the study

               -  be willing to use a reliable form of contraception during the study

          -  Be willing and able to comply with the scheduled visits and other study procedures for
             the duration of the study.

          -  Be willing not to take any other medicine for acne or rosacea during the study

          -  Acne specific inclusion criteria:

             o 10-100 noninflammatory, 20-50 inflammatory lesions (nose excluded)

          -  Rosacea specific inclusion criteria:

               -  History of frequent flushing

               -  Skin erythema - Positive (not negative) chromometer minimum reading difference
                  when subtracting nonaffected reading from affected reading.

        Goal would be greater than 1 unit difference between red areas. For example, the red area
        (average 17.7 Chroma Meter a) and nonaffected areas (average 14.1 Chroma Meter a), yields
        in an optimum scenario greater than 3 point difference in this example (in subjects with
        average Chromometer L value averaging 56.6-59.6). Example from (Helfrich et al., 2015).

        o Presence of inflammatory papules

        Exclusion Criteria:

          -  Having received any investigational drug within 30 days prior to study entry

          -  An allergy history to any study materials including any beta-blockers.

          -  Pregnant, lactating, or trying to become pregnant

          -  Severe depression

          -  Hypotension or history

          -  Bradycardia or history

          -  History of Cardiac Heart Failure

          -  History of Myocardial infarction

          -  History of heart arrhythmia

          -  Asthma or Bronchospasm or history

          -  Rosacea specific exclusion criteria:

        Recent topicals within 3 weeks Oral rosacea medications such as antibiotics within 3 weeks
        • Acne specific exclusion criteria: nodular acne man with beard which interferes with
        clinical evaluation history of Accutane Oral contraceptive pills changes last 3 months
        Topical retinoid within 4 weeks Cosmetic procedures (like facial or peels) for 4 weeks
        Photodynamic therapy , laser therapy or microdermabrasion for 4 weeks Other topicals or
        oral acne medications such as antibiotics within 3 weeks

        o Biopsy volunteer specific exclusion criteria: History of keloids History of hypertrophic
        scars Allergy to lidocaine or epinephrine
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.
Subject must be at most 65 Years

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? 1