Erythema, Rosacea
Conditions
Brief summary
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.
Detailed description
Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.
Interventions
DRUGCD07805/47 gel 0.5%/CD07805/47 Vehicle
To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily
DRUGazelaic acid gel 15%
During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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
1. Subject is male or female aged 18 years or older. 2. Subject has a clinical diagnosis of facial rosacea. 3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment. 4. Subject has a self assessment score of moderate to severe redness prior to enrollment. 5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.
Exclusion criteria
1. Female subjects who are pregnant, nursing or planning a pregnancy during the study. 2. Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study. 3. Subjects with conditions causing facial erythema which would confound the assessment of treatment. 4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists. 5. Subjects with known allergies or sensitivities to one of the components of the investigational products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Success | Hour 6 on Day 15 | Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Action | 30 minutes after baseline treatment application on Day 15 | Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants were randomly assigned to treatment sequence.
Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.
Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.
Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout , 3 to 7 Days | Adverse Event | 1 | 0 |
| Washout , 3 to 7 Days | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants |
| Age, Continuous | 52.4 years STANDARD_DEVIATION 10.9 |
| Fitzpatrick skin type I | 6 participants |
| Fitzpatrick skin type II | 35 participants |
| Fitzpatrick skin type III | 24 participants |
| Fitzpatrick skin type IV | 4 participants |
| Fitzpatrick skin type V | 1 participants |
| Fitzpatrick skin type VI | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 18 Participants |
| Skin type Combination | 17 participants |
| Skin type Dry | 14 participants |
| Skin type Normal | 33 participants |
| Skin type Oily | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 70 | 27 / 68 |
| serious Total, serious adverse events | 0 / 70 | 0 / 68 |
Outcome results
Primary
Composite Success
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Time frame: Hour 6 on Day 15
Population: A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD07805/47 Gel 0.5% and Vehicle | Composite Success | 14.3 percentage of subjects |
| Azelaic Acid Gel 15% | Composite Success | 5.7 percentage of subjects |
Secondary
Onset of Action
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Time frame: 30 minutes after baseline treatment application on Day 15
Population: A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD07805/47 Gel 0.5% and Vehicle | Onset of Action | 31.4 percentage of subjects |
| Azelaic Acid Gel 15% | Onset of Action | 29.4 percentage of subjects |