Trial Outcomes & Findings for Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne (NCT NCT01701024)
NCT ID: NCT01701024
Last Updated: 2018-06-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
498 participants
Primary outcome timeframe
Baseline and 12 Weeks
Results posted on
2018-06-04
Participant Flow
Participant milestones
| Measure |
ACYC
ACYC active, topically applied to the face for 12 weeks
|
ACYC Vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
253
|
245
|
|
Overall Study
COMPLETED
|
243
|
236
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
Baseline characteristics by cohort
| Measure |
ACYC
n=253 Participants
ACYC active, topically applied to the face for 12 weeks
|
ACYC Vehicle
n=245 Participants
ACYC vehicle (placebo), topically applied to the face for 12 weeks
|
Total
n=498 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.2 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
19.3 years
STANDARD_DEVIATION 6 • n=7 Participants
|
18.7 years
STANDARD_DEVIATION 5.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
208 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Inflammatory Lesion Count
|
27.2 Lesions
STANDARD_DEVIATION 5.99 • n=5 Participants
|
26.7 Lesions
STANDARD_DEVIATION 6.09 • n=7 Participants
|
27 Lesions
STANDARD_DEVIATION 6.04 • n=5 Participants
|
|
Non-Inflammatory Lesion Count
|
38.3 Lesions
STANDARD_DEVIATION 18.63 • n=5 Participants
|
37.2 Lesions
STANDARD_DEVIATION 17.07 • n=7 Participants
|
37.8 Lesions
STANDARD_DEVIATION 17.87 • n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
Almost Clear
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
Mild
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
Moderate
|
212 participants
n=5 Participants
|
200 participants
n=7 Participants
|
412 participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
Severe
|
41 participants
n=5 Participants
|
45 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Evaluator's Global Severity Score (EGSS)
Very Severe
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksOutcome measures
| Measure |
ACYC
n=253 Participants
ACYC active, topically applied to the face for 12 weeks
|
ACYC Vehicle
n=245 Participants
ACYC vehicle (placebo), topically applied to the face for 12 weeks
|
|---|---|---|
|
Absolute Change in Inflammatory Lesion Count
|
16.3 Lesion count
Standard Deviation 9.75
|
8.2 Lesion count
Standard Deviation 11.55
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksOutcome measures
| Measure |
ACYC
n=253 Participants
ACYC active, topically applied to the face for 12 weeks
|
ACYC Vehicle
n=245 Participants
ACYC vehicle (placebo), topically applied to the face for 12 weeks
|
|---|---|---|
|
Absolute Change in Non-inflammatory Lesion Count
|
19.2 lesion count
Standard Deviation 16.18
|
9.6 lesion count
Standard Deviation 17.49
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksOutcome measures
| Measure |
ACYC
n=253 Participants
ACYC active, topically applied to the face for 12 weeks
|
ACYC Vehicle
n=245 Participants
ACYC vehicle (placebo), topically applied to the face for 12 weeks
|
|---|---|---|
|
Percent of Subjects Who Have a Least a 2 Grade Reduction
|
35.2 Percent with >2% reduction
|
17 Percent with >2% reduction
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksOutcome measures
| Measure |
ACYC
n=253 Participants
ACYC active, topically applied to the face for 12 weeks
|
ACYC Vehicle
n=245 Participants
ACYC vehicle (placebo), topically applied to the face for 12 weeks
|
|---|---|---|
|
Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
|
28.5 percentage of clear or almost clear
|
14.5 percentage of clear or almost clear
|
Adverse Events
ACYC
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
ACYC Vehicle
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACYC
n=243 participants at risk
ACYC active, topically applied to the face for 12 weeks
|
ACYC Vehicle
n=236 participants at risk
ACYC vehicle (placebo), topically applied to the face for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/243
|
1.3%
3/236
|
|
Nervous system disorders
Headache
|
1.2%
3/243
|
2.1%
5/236
|
|
Infections and infestations
Influenza
|
2.1%
5/243
|
2.1%
5/236
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
18/243
|
5.1%
12/236
|
|
General disorders
Pyrexia
|
1.2%
3/243
|
0.85%
2/236
|
|
Infections and infestations
Sinusitis
|
2.9%
7/243
|
0.42%
1/236
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.82%
2/243
|
1.3%
3/236
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place