Clinical trial: CGB-400 for the Reduction of Facial Redness (NCT04508660)

Eligibility criteria:
Inclusion Criteria:

          1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of
             childbearing potential must have a negative UPT at Baseline and practice a reliable
             method of contraception throughout the study.

          2. Facial redness associated with rosacea.

          3. Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).

          4. Absence of any skin conditions that could interfere with the visual erythema
             assessments.

          5. Willing to forego any other topical or non-topical treatment on the study areas during
             treatment (other than sun protection or the study specified face wash and
             moisturizer).

          6. Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over
             the duration of the study.

          7. Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures
             being performed.

        Exclusion Criteria:

          1. Known hypersensitivity or previous allergic reaction to any constituent of the
             Investigational Products (i.e., essential oils, fragrance, choline,
             phosphatidylcholine, etc.).

          2. Any transient flushing syndrome.

          3. History of basal cell carcinoma within 6 months of Visit 1.

          4. History or presence of a skin condition/disease that is located in the treatment
             area(s) and might interfere with the diagnosis or evaluation of study parameters
             (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open
             wounds, infection, etc.).

          5. Diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans
             at Baseline.

          6. Blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist.

          7. Uncontrolled systemic disease.

          8. Foreseen unprotected and intense/excessive UV exposure during the course of the study.

          9. Use of any of the following concomitant medications/procedures:

               -  Cosmetic and/or OTC products for redness reduction and/or skin clearing

               -  Topical medications for rosacea

               -  Systemic antibiotics or corticosteroids

               -  Topical antibiotics, corticosteroids, or antiparasitic agents

               -  Intense/excessive ultraviolet (UV) radiation

               -  Phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion

         10. Exposure to any other investigational drug/device within 30 days prior to study entry.
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