Phase 2
Completed N=20
Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Erythematous Rosacea
Source: ClinicalTrials.gov NCT00697541 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Cmax - Maximum Systemic Concentration of Brimonidine — NA; NA pg/mL
Summary
Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax - Maximum Systemic Concentration of Brimonidine |
NA; NA | — |
| PRIMARY AUC - Area Under the Curve of Brimonidine |
NA; NA | — |
| PRIMARY Tmax - Time to Maximum Plasma Concentration |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥18 years of age
- Clinical diagnosis of rosacea
- A score of ≥ 3 on the CEAS
- A score of ≥ 3 on the PSA
- IOP ≥ 10 mm Hg
- Non-pregnant and non-lactating females
Exclusion Criteria
- History of hypersensitivity or allergies to any ingredient of the study drugs, unless approved by the Investigator
- Use of brimonidine prescription medications within 14 days prior to Check-in
- Use of any over-the-counter (OTC), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to Check-in, unless deemed acceptable by the Investigator
- Use of systemic or topical steroids applied to the face 14 days prior to Check in
- The use of any Rx or OTC products for the treatment of acne or rosacea within 14 days prior to check in
- The use of isotretinoin within 180 days prior to check in
Data sourced from ClinicalTrials.gov (NCT00697541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.