Trial Outcomes & Findings for A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (NCT NCT05296629)
NCT ID: NCT05296629
Last Updated: 2024-12-03
Results Overview
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
323 participants
Primary outcome timeframe
Baseline to Week 16.
Results posted on
2024-12-03
Participant Flow
Participant milestones
| Measure |
DFD-29
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg Capsule
Doxycycline 40 mg capsule administered once daily for 16 weeks
|
Placebo
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
121
|
80
|
|
Overall Study
COMPLETED
|
117
|
98
|
73
|
|
Overall Study
NOT COMPLETED
|
5
|
23
|
7
|
Reasons for withdrawal
| Measure |
DFD-29
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg Capsule
Doxycycline 40 mg capsule administered once daily for 16 weeks
|
Placebo
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
1
|
|
Overall Study
Adverse Event
|
0
|
4
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
0
|
Baseline Characteristics
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
Baseline characteristics by cohort
| Measure |
DFD-29
n=122 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg Capsule
n=121 Participants
Doxycycline 40 mg capsule administered once daily for 16 weeks
|
Placebo
n=80 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 13.16 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 14.11 • n=7 Participants
|
47.2 years
STANDARD_DEVIATION 14.09 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 13.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
247 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=5 Participants
|
121 participants
n=7 Participants
|
80 participants
n=5 Participants
|
323 participants
n=4 Participants
|
|
Investigators Global Assessment (IGA) grade
Moderate
|
101 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
279 Participants
n=4 Participants
|
|
Investigators Global Assessment (IGA) grade
Severe
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Total Inflammatory Lesion Count
|
26.4 Lesion count
STANDARD_DEVIATION 10.46 • n=5 Participants
|
23.8 Lesion count
STANDARD_DEVIATION 8.75 • n=7 Participants
|
25.9 Lesion count
STANDARD_DEVIATION 8.84 • n=5 Participants
|
25.3 Lesion count
STANDARD_DEVIATION 9.50 • n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) score
0 = None
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) score
1 = Mild
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) score
2 = Moderate
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
127 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) score
3 = Significant
|
57 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
|
Clinician's Erythema Assessment (CEA) score
4 = Severe
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16.Population: ITT population defined as, 'All randomized subjects'
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Outcome measures
| Measure |
DFD-29
n=122 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=80 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Investigator's Global Assessment (IGA) Treatment Success Compared to Placebo.
|
79 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16.Population: ITT Population
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
Outcome measures
| Measure |
DFD-29
n=122 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=80 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Change in Total Inflammatory Lesion Count Compared to Placebo.
|
-20.6 lesions
Standard Error 0.77
|
-11.4 lesions
Standard Error 0.97
|
SECONDARY outcome
Timeframe: Baseline to Week 16.Population: ITT Population
Proportion of subjects with IGA treatment success at week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Outcome measures
| Measure |
DFD-29
n=122 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=121 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
IGA Treatment Success Compared to Doxycycline.
|
79 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16.Population: ITT Population
Total inflammatory lesion count change from Baseline to week 16 in the DFD-29 group compared to Doxycycline capsules 40 mg.
Outcome measures
| Measure |
DFD-29
n=122 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=121 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Change in Total Inflammatory Lesion Count Compared to Doxycycline.
|
-20.6 lesions
Standard Error 0.69
|
-15.6 lesions
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline to Week 16.Population: ITT Population
Proportion of subjects with at least 2-grade reduction in CEA score from Baseline to Week 16 in the DFD-29 group compared to Placebo.
Outcome measures
| Measure |
DFD-29
n=122 Participants
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Placebo
n=80 Participants
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|
|
Clinician's Erythema Assessment (CEA) Compared to Placebo.
|
39 Participants
|
11 Participants
|
Adverse Events
DFD-29
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Doxycycline 40 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DFD-29
n=121 participants at risk
DFD-29 (40 mg) extended release capsules
DFD-29: DFD-29 (40 mg) extended release capsules
|
Doxycycline 40 mg
n=116 participants at risk
Doxycycline 40 mg modified release capsules
Doxycycline: Doxycycline 40 mg capsules
|
Placebo
n=76 participants at risk
Placebo capsules matching DFD-29
Placebo: Placebo capsules
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
3.3%
4/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
2.6%
3/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
5.3%
4/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
4/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
3.9%
3/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Infections and infestations
Vulvovaginal mycotic infections
|
1.7%
2/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
2/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
3.9%
3/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
3.4%
4/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
2.6%
2/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Nervous system disorders
Headache
|
2.5%
3/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
3.9%
3/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.83%
1/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
2.6%
2/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Vascular disorders
Hypertension
|
0.83%
1/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.3%
1/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/121 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
1.7%
2/116 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
0.00%
0/76 • From the signing of informed consent up to 16 weeks of study treatment.
AEs were collected by spontaneous reports from subjects, either verbal or recorded in the subject's diary, by directed questioning of subjects, and by observation. The number of participants at risk for safety assessments were drawn from the safety population. Hence, they are slightly different from the efficacy assessments where the ITT population was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place