Rosacea
Conditions
Brief summary
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Interventions
DRUGDER 45 EV
Topical application to face for 12 weeks
DRUGVehicle
Topical application to face for 12 weeks
Sponsors
Sol-Gel Technologies, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females, 18 years of age or older * Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules) * Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA * Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study
Exclusion criteria
* Subjects who are pregnant, breast feeding, or planning a pregnancy during the study * Allergy or sensitivity to ingredients in test product * Any dermatological conditions of the face that may interfere with study evaluations * Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) Improvement From Baseline | Baseline to Week 12 / end of treatment | The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe). |
| Change in Inflammatory Lesion Counts From Baseline | Baseline to Week 12 / end of treatment | The LS mean changes from Baseline in inflammatory lesion count at Week 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DER 45 EV Gel, 1% DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks | 32 |
| Vehicle Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks | 30 |
| DER 45 EV Gel, 5% DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks | 30 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | subject request | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | DER 45 EV Gel, 1% | Vehicle | DER 45 EV Gel, 5% | Total |
|---|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 13.5 | 50.5 years STANDARD_DEVIATION 12.56 | 52.2 years STANDARD_DEVIATION 12.66 | 51.2 years STANDARD_DEVIATION 12.8 |
| number of inflammatory lesions | 28.6 number of inflammatory lesion STANDARD_DEVIATION 27.76 | 19.9 number of inflammatory lesion STANDARD_DEVIATION 8.64 | 22.9 number of inflammatory lesion STANDARD_DEVIATION 16.89 | 23.9 number of inflammatory lesion STANDARD_DEVIATION 19.76 |
| Region of Enrollment United States | 32 participants | 30 participants | 30 participants | 92 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 23 Participants | 67 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 7 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 32 | 11 / 30 | 7 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in Inflammatory Lesion Counts From Baseline
The LS mean changes from Baseline in inflammatory lesion count at Week 12.
Time frame: Baseline to Week 12 / end of treatment
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| DER 45 EV Gel, 1% | Change in Inflammatory Lesion Counts From Baseline | -21.5 Inflammatory lesions |
| Vehicle | Change in Inflammatory Lesion Counts From Baseline | -8.8 Inflammatory lesions |
| DER 45 EV Gel, 5% | Change in Inflammatory Lesion Counts From Baseline | -14.7 Inflammatory lesions |
Primary
Investigator Global Assessment (IGA) Improvement From Baseline
The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).
Time frame: Baseline to Week 12 / end of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DER 45 EV Gel, 1% | Investigator Global Assessment (IGA) Improvement From Baseline | 37.5 percentage of subjects |
| Vehicle | Investigator Global Assessment (IGA) Improvement From Baseline | 20.0 percentage of subjects |
| DER 45 EV Gel, 5% | Investigator Global Assessment (IGA) Improvement From Baseline | 53.3 percentage of subjects |