Trial Outcomes & Findings for A Study of DER 45-EV Gel to Treat Rosacea (NCT NCT00940992)
NCT ID: NCT00940992
Last Updated: 2015-01-09
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Baseline to Week 12 / end of treatment
Results posted on
2015-01-09
Participant Flow
Participant milestones
| Measure |
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
|
Vehicle
Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
Vehicle
Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks
|
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
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
subject request
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
A Study of DER 45-EV Gel to Treat Rosacea
Baseline characteristics by cohort
| Measure |
DER 45 EV Gel, 1%
n=32 Participants
DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
Vehicle
n=30 Participants
Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks
|
DER 45 EV Gel, 5%
n=30 Participants
DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 13.50 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 12.56 • n=7 Participants
|
52.2 years
STANDARD_DEVIATION 12.66 • n=5 Participants
|
51.2 years
STANDARD_DEVIATION 12.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
number of inflammatory lesions
|
28.6 number of inflammatory lesion
STANDARD_DEVIATION 27.76 • n=5 Participants
|
19.9 number of inflammatory lesion
STANDARD_DEVIATION 8.64 • n=7 Participants
|
22.9 number of inflammatory lesion
STANDARD_DEVIATION 16.89 • n=5 Participants
|
23.9 number of inflammatory lesion
STANDARD_DEVIATION 19.76 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12 / end of treatmentThe 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).
Outcome measures
| Measure |
DER 45 EV Gel, 1%
n=32 Participants
DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
Vehicle
n=30 Participants
Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks
|
DER 45 EV Gel, 5%
n=30 Participants
DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
|---|---|---|---|
|
Investigator Global Assessment (IGA) Improvement From Baseline
|
37.5 percentage of subjects
|
20.0 percentage of subjects
|
53.3 percentage of subjects
|
PRIMARY outcome
Timeframe: Baseline to Week 12 / end of treatmentThe LS mean changes from Baseline in inflammatory lesion count at Week 12.
Outcome measures
| Measure |
DER 45 EV Gel, 1%
n=32 Participants
DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
Vehicle
n=30 Participants
Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks
|
DER 45 EV Gel, 5%
n=30 Participants
DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
|---|---|---|---|
|
Change in Inflammatory Lesion Counts From Baseline
|
-21.5 Inflammatory lesions
Interval -27.5 to -15.4
|
-8.8 Inflammatory lesions
Interval -15.1 to -2.5
|
-14.7 Inflammatory lesions
Interval -21.0 to -8.4
|
Adverse Events
DER 45 EV Gel, 1%
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
DER 45 EV Gel, 5%
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DER 45 EV Gel, 1%
n=32 participants at risk
DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
Vehicle
n=30 participants at risk
Placebo Gel applied topically once a day for 12 weeks
Vehicle: Topical application to face for 12 weeks
|
DER 45 EV Gel, 5%
n=30 participants at risk
DER 45 EV Gel, 5% applied topically once a day for 12 weeks
DER 45 EV: Topical application to face for 12 weeks
|
|---|---|---|---|
|
General disorders
Application site dermatitis
|
3.1%
1/32 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
General disorders
Application site erythema
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
General disorders
Application site pain
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
General disorders
Application site pruritus
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
General disorders
Application site reaction
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
General disorders
Cyst
|
3.1%
1/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
|
Infections and infestations
Fungal infection
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
10.0%
3/30 • 12 weeks
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
1/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
|
Nervous system disorders
Migraine
|
3.1%
1/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/32 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Psychiatric disorders
Panic attack
|
3.1%
1/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.1%
1/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/32 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
3.3%
1/30 • 12 weeks
|
Additional Information
Ofra Levy-Hacham, Ph.D, VP of Quality Assurance
Solgel
Phone: 972-8-9313433
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER