Erythematotelangiectatic Rosacea
Conditions
Keywords
Erythematotelangiectatic, Rosacea
Brief summary
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
Interventions
DRUGCD07805/47
0.5% Topical Gel
DRUGCD07805/47 placebo
Vehicle Topical Gel
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female who is at least 18 years of age. * Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. * CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline. * PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline. * Presence of 2 or fewer inflammatory facial lesions.
Exclusion criteria
* History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression. * History of refractive surgery such as photorefractive keratectomy. * The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants. * The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. | Baseline and every hour for 12 hours following application |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD07805/47 0.5% Topical Gel 0.5% Topical Gel | 31 |
| CD07805/47 0.18% Topical Gel 0.18% Topical Gel | 31 |
| CD07805/47 0.07% Topical Gel 0.07% Topical Gel | 28 |
| CD07805/47 Vehicle Topical Gel Vehicle Topical Gel | 32 |
| Total | 122 |
Baseline characteristics
| Characteristic | CD07805/47 0.18% Topical Gel | CD07805/47 0.07% Topical Gel | CD07805/47 0.5% Topical Gel | CD07805/47 Vehicle Topical Gel | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 27 Participants | 31 Participants | 29 Participants | 117 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 12.37 | 43.7 years STANDARD_DEVIATION 10.74 | 45.8 years STANDARD_DEVIATION 11.87 | 46.7 years STANDARD_DEVIATION 13.35 | 45.7 years STANDARD_DEVIATION 12.06 |
| Region of Enrollment United States | 31 participants | 28 participants | 31 participants | 32 participants | 122 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 25 Participants | 24 Participants | 92 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 6 Participants | 8 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 31 | 1 / 31 | 3 / 28 | 5 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 28 | 0 / 32 |
Outcome results
Primary
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
Time frame: Baseline and every hour for 12 hours following application
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD07805/47 0.5% Topical Gel | Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. | 17 participants |
| CD07805/47 0.18% Topical Gel | Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. | 10 participants |
| CD07805/47 0.07% Topical Gel | Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. | 7 participants |
| CD07805/47 Vehicle Topical Gel | Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. | 4 participants |