Trial Outcomes & Findings for Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris (NCT NCT01320033)
NCT ID: NCT01320033
Last Updated: 2021-02-18
Results Overview
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.
COMPLETED
PHASE2
662 participants
From Baseline up to Week 16 (LOCF)
2021-02-18
Participant Flow
This study was conducted in United States between 29 March 2011 (first participant first visit) to 3 January 2012 (last participant last visit).
A total of 662 participants randomized the study and dispensed with study drug out of which 487 completed study.
Participant milestones
| Measure |
CD2475/101 40 mg
Participants received 40 milligrams (mg) of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
216
|
224
|
222
|
|
Overall Study
COMPLETED
|
158
|
160
|
169
|
|
Overall Study
NOT COMPLETED
|
58
|
64
|
53
|
Reasons for withdrawal
| Measure |
CD2475/101 40 mg
Participants received 40 milligrams (mg) of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
9
|
7
|
8
|
|
Overall Study
Withdrawal by Subject
|
22
|
23
|
23
|
|
Overall Study
Protocol Violation
|
3
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
22
|
26
|
17
|
|
Overall Study
Other
|
2
|
3
|
1
|
Baseline Characteristics
Placebo Controlled Efficacy and Safety Study of CD2475/101 40 mg Tablets vs. Placebo and Doxycycline 100 mg Capsules Once Daily in the Treatment of Inflammatory Lesions of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=224 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
Total
n=662 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
123 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
388 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
19.6 Years
STANDARD_DEVIATION 7.70 • n=5 Participants
|
19.6 Years
STANDARD_DEVIATION 7.54 • n=7 Participants
|
18.7 Years
STANDARD_DEVIATION 6.34 • n=5 Participants
|
19.3 Years
STANDARD_DEVIATION 7.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
351 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
181 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
560 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 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
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
159 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
492 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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
216 participants
n=5 Participants
|
224 participants
n=7 Participants
|
222 participants
n=5 Participants
|
662 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 16 (LOCF)Population: Intent To Treat (ITT) population consisted of all participants who were randomized and to whom study drug was dispensed.
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.
Outcome measures
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=224 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
|
-16.1 lesion count
Standard Deviation 11.39
|
-12.9 lesion count
Standard Deviation 14.60
|
-12.6 lesion count
Standard Deviation 16.44
|
SECONDARY outcome
Timeframe: Week 16 (LOCF)Population: ITT Population consisted of all participants who were randomized and to whom study drug was dispensed.
IGA scale consisted of 5 grades (0-4) among which 0= Clear (no evidence of papules or pustules \[inflammatory lesions\]), 1= Almost clear (rare non-inflamed papules (papules must be resolving and hyperpigmented, though not pink-red), 2= Mild (few inflammatory lesions \[papules/pustules only; no nodulo-cystic lesions\]), 3=Moderate (multiple inflammatory lesions evident: many papules/pustules; up to two nodulocystic lesions), 4= Severe (inflammatory lesions are more apparent, many papules/pustules, few nodulo-cystic lesions). Success rate was defined as percentage of participants who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16 (LOCF).
Outcome measures
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=224 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Investigator Global Assessment (IGA) Success Rate at Week 16 (Last Observation Carried Forward [LOCF])
|
14.4 Percentage of participants
|
13.8 Percentage of participants
|
7.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline up to Week 16 (LOCF)Population: ITT population consisted of all participants who were randomized and to whom study drug was dispensed.
The Inflammatory lesion count was the count of papules and pustules: papule was a small, solid elevation less than 0.5 cm in diameter, pustule was a small, circumscribed elevation of the skin that contains yellow-white exudate. Percent change from baseline in inflammatory lesion counts to Week 16 (LOCF) were reported.
Outcome measures
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=224 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
|
-48.6 percent change
Standard Deviation 31.72
|
-40.3 percent change
Standard Deviation 40.90
|
-37.1 percent change
Standard Deviation 44.45
|
SECONDARY outcome
Timeframe: From Baseline up to Week 16 (LOCF)Population: ITT population consisted of all participants who were randomized and to whom study drug was dispensed.
Total lesions were the sum of inflammatory lesion counts, non-inflammatory lesion counts, nodules and cysts. Percentage change from baseline in total lesion counts to Week 16 were reported.
Outcome measures
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=224 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Percent Change From Baseline in Total Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
|
-38.3 percent change
Standard Deviation 32.24
|
-27.8 percent change
Standard Deviation 43.94
|
-27.8 percent change
Standard Deviation 38.05
|
SECONDARY outcome
Timeframe: From Baseline up to Week 16 (LOCF)Population: ITT population consisted of all participants who were randomized and to whom study drug was dispensed.
The non-inflammatory lesion count was the count of open and closed comedones: Open comedone was a pigmented dilated pilosebaceous orifice (blackhead). Closed comedone was a tiny white papule (whitehead). Change from baseline in non-inflammatory lesion counts to week 16 were reported
Outcome measures
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=224 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Change From Baseline in Non-Inflammatory Lesion Counts to Week 16 (Last Observation Carried Forward [LOCF])
|
-10.0 lesion count
Standard Deviation 21.49
|
-5.2 lesion count
Standard Deviation 21.60
|
-5.8 lesion count
Standard Deviation 18.19
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 16Population: ITT population consisted of all participants who were randomized and to whom study drug was dispensed.
Global assessments for inflammatory lesions of truncal acne were done separately on back and chest. The global assessments severity scale included 5 grades (0-4): where in 0= Clear-no evidence of papules or pustules (inflammatory lesions), 1= Almost clear- rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red), 2=Mild- few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions), 3=Moderate- multiple inflammatory lesions evident: many papules/pustules; may be a few nodulocystic lesions, 4=Severe- inflammatory lesions are more apparent, many papules/pustules, may be a few nodulo-cystic lesions.
Outcome measures
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=224 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Baseline : Lesion of Truncal Acne on Back
|
1.6 Units on a scale
Standard Deviation 1.10
|
1.5 Units on a scale
Standard Deviation 1.09
|
1.5 Units on a scale
Standard Deviation 1.07
|
|
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Baseline : Lesion of Truncal Acne on Chest
|
1.2 Units on a scale
Standard Deviation 1.04
|
1.2 Units on a scale
Standard Deviation 1.00
|
1.1 Units on a scale
Standard Deviation 0.98
|
|
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Week 12 : Lesions of Truncal Acne on Back
|
1.2 Units on a scale
Standard Deviation 1.06
|
1.1 Units on a scale
Standard Deviation 1.05
|
1.2 Units on a scale
Standard Deviation 1.04
|
|
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Week 12 : Lesion of Truncal Acne on Chest
|
0.9 Units on a scale
Standard Deviation 0.94
|
0.9 Units on a scale
Standard Deviation 0.99
|
0.9 Units on a scale
Standard Deviation 0.95
|
|
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Week 16 : Lesions of Truncal Acne on Back
|
1.1 Units on a scale
Standard Deviation 1.06
|
1.0 Units on a scale
Standard Deviation 1.06
|
1.2 Units on a scale
Standard Deviation 1.03
|
|
Global Assessment for Inflammatory Lesions of Truncal Acne at Baseline, Week 12, and Week 16
Week 16 : Lesion of Truncal Acne on Chest
|
0.9 Units on a scale
Standard Deviation 1.01
|
0.8 Units on a scale
Standard Deviation 0.93
|
0.9 Units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: From Baseline up to Week 16Population: Safety Population consisted of all participants who received at least one dose of study drug.
An AE was any untoward medical occurrence in a participant or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Number of participants with at least one AE were reported.
Outcome measures
| Measure |
CD2475/101 40 mg
n=216 Participants
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=223 Participants
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 Participants
Participants received matching placebo tablet plus placebo capsule orally once daily for 16 weeks.
|
|---|---|---|---|
|
Number of Participants With at Least One Adverse Event (AE)
|
63 Participants
|
83 Participants
|
89 Participants
|
Adverse Events
CD2475/101 40 mg
Doxycycline 100 mg
Placebo
Serious adverse events
| Measure |
CD2475/101 40 mg
n=216 participants at risk
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=223 participants at risk
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 participants at risk
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Affective disorder
|
0.46%
1/216 • From Baseline up to Week 16
|
0.00%
0/223 • From Baseline up to Week 16
|
0.00%
0/222 • From Baseline up to Week 16
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/216 • From Baseline up to Week 16
|
0.00%
0/223 • From Baseline up to Week 16
|
0.45%
1/222 • From Baseline up to Week 16
|
|
Psychiatric disorders
Depression
|
0.00%
0/216 • From Baseline up to Week 16
|
0.45%
1/223 • From Baseline up to Week 16
|
0.45%
1/222 • From Baseline up to Week 16
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/216 • From Baseline up to Week 16
|
0.00%
0/223 • From Baseline up to Week 16
|
0.45%
1/222 • From Baseline up to Week 16
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/216 • From Baseline up to Week 16
|
0.45%
1/223 • From Baseline up to Week 16
|
0.00%
0/222 • From Baseline up to Week 16
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/216 • From Baseline up to Week 16
|
0.45%
1/223 • From Baseline up to Week 16
|
0.00%
0/222 • From Baseline up to Week 16
|
|
Injury, poisoning and procedural complications
Multiple drug overdose intentional
|
0.00%
0/216 • From Baseline up to Week 16
|
0.00%
0/223 • From Baseline up to Week 16
|
0.45%
1/222 • From Baseline up to Week 16
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/216 • From Baseline up to Week 16
|
0.45%
1/223 • From Baseline up to Week 16
|
0.00%
0/222 • From Baseline up to Week 16
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/216 • From Baseline up to Week 16
|
0.00%
0/223 • From Baseline up to Week 16
|
0.45%
1/222 • From Baseline up to Week 16
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/216 • From Baseline up to Week 16
|
0.00%
0/223 • From Baseline up to Week 16
|
0.45%
1/222 • From Baseline up to Week 16
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/216 • From Baseline up to Week 16
|
0.45%
1/223 • From Baseline up to Week 16
|
0.00%
0/222 • From Baseline up to Week 16
|
Other adverse events
| Measure |
CD2475/101 40 mg
n=216 participants at risk
Participants received 40 mg of CD2475/101 oral tablet plus placebo capsule orally once daily for 16 weeks.
|
Doxycycline 100 mg
n=223 participants at risk
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
Placebo
n=222 participants at risk
Participants received 100 mg of Doxycycline capsule plus placebo tablet orally once daily for 16 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.2%
7/216 • From Baseline up to Week 16
|
3.1%
7/223 • From Baseline up to Week 16
|
6.3%
14/222 • From Baseline up to Week 16
|
|
Nervous system disorders
Headache
|
6.5%
14/216 • From Baseline up to Week 16
|
6.7%
15/223 • From Baseline up to Week 16
|
2.7%
6/222 • From Baseline up to Week 16
|
|
Gastrointestinal disorders
Nausea
|
3.2%
7/216 • From Baseline up to Week 16
|
6.3%
14/223 • From Baseline up to Week 16
|
1.8%
4/222 • From Baseline up to Week 16
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
1/216 • From Baseline up to Week 16
|
6.7%
15/223 • From Baseline up to Week 16
|
2.3%
5/222 • From Baseline up to Week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place