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Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne (ACYC)

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ClinicalTrials.gov Identifier: NCT01701024
Recruitment Status : Completed
First Posted : October 4, 2012
Results First Posted : January 10, 2017
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: ACYC
Drug: ACYC vehicle
Enrollment 498
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACYC ACYC Vehicle
Hide Arm/Group Description ACYC active, topically applied to the face for 12 weeks ACYC vehicle (placebo), topically applied to the face for 12 weeks
Period Title: Overall Study
Started 253 245
Completed 243 236
Not Completed 10 9
Arm/Group Title ACYC ACYC Vehicle Total
Hide Arm/Group Description ACYC active, topically applied to the face for 12 weeks ACYC vehicle (placebo), topically applied to the face for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 253 245 498
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 253 participants 245 participants 498 participants
18.2  (5.6) 19.3  (6) 18.7  (5.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 245 participants 498 participants
Female
123
  48.6%
119
  48.6%
242
  48.6%
Male
130
  51.4%
126
  51.4%
256
  51.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 245 participants 498 participants
Hispanic or Latino
64
  25.3%
72
  29.4%
136
  27.3%
Not Hispanic or Latino
189
  74.7%
173
  70.6%
362
  72.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 245 participants 498 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   2.4%
4
   1.6%
10
   2.0%
Native Hawaiian or Other Pacific Islander
1
   0.4%
1
   0.4%
2
   0.4%
Black or African American
33
  13.0%
24
   9.8%
57
  11.4%
White
208
  82.2%
210
  85.7%
418
  83.9%
More than one race
5
   2.0%
6
   2.4%
11
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Inflammatory Lesion Count  
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 253 participants 245 participants 498 participants
27.2  (5.99) 26.7  (6.09) 27  (6.04)
Non-Inflammatory Lesion Count  
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 253 participants 245 participants 498 participants
38.3  (18.63) 37.2  (17.07) 37.8  (17.87)
Evaluator's Global Severity Score (EGSS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 253 participants 245 participants 498 participants
Clear 0 0 0
Almost Clear 0 0 0
Mild 0 0 0
Moderate 212 200 412
Severe 41 45 86
Very Severe 0 0 0
1.Primary Outcome
Title Absolute Change in Inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACYC ACYC Vehicle
Hide Arm/Group Description:
ACYC active, topically applied to the face for 12 weeks
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Overall Number of Participants Analyzed 253 245
Mean (Standard Deviation)
Unit of Measure: Lesion count
16.3  (9.75) 8.2  (11.55)
2.Primary Outcome
Title Absolute Change in Non-inflammatory Lesion Count
Hide Description [Not Specified]
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACYC ACYC Vehicle
Hide Arm/Group Description:
ACYC active, topically applied to the face for 12 weeks
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Overall Number of Participants Analyzed 253 245
Mean (Standard Deviation)
Unit of Measure: lesion count
19.2  (16.18) 9.6  (17.49)
3.Primary Outcome
Title Percent of Subjects Who Have a Least a 2 Grade Reduction
Hide Description [Not Specified]
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACYC ACYC Vehicle
Hide Arm/Group Description:
ACYC active, topically applied to the face for 12 weeks
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Overall Number of Participants Analyzed 253 245
Measure Type: Number
Unit of Measure: Percent with >2% reduction
35.2 17
4.Primary Outcome
Title Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
Hide Description [Not Specified]
Time Frame Baseline and 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACYC ACYC Vehicle
Hide Arm/Group Description:
ACYC active, topically applied to the face for 12 weeks
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Overall Number of Participants Analyzed 253 245
Measure Type: Number
Unit of Measure: percentage of clear or almost clear
28.5 14.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACYC ACYC Vehicle
Hide Arm/Group Description ACYC active, topically applied to the face for 12 weeks ACYC vehicle (placebo), topically applied to the face for 12 weeks
All-Cause Mortality
ACYC ACYC Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACYC ACYC Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/243 (0.00%)   0/236 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
ACYC ACYC Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   38/243 (15.64%)   31/236 (13.14%) 
Gastrointestinal disorders     
Abdominal Pain *  0/243 (0.00%)  3/236 (1.27%) 
General disorders     
Pyrexia *  3/243 (1.23%)  2/236 (0.85%) 
Infections and infestations     
Influenza *  5/243 (2.06%)  5/236 (2.12%) 
Nasopharyngitis *  18/243 (7.41%)  12/236 (5.08%) 
Sinusitis *  7/243 (2.88%)  1/236 (0.42%) 
Upper Respiratory Tract Infection *  2/243 (0.82%)  3/236 (1.27%) 
Nervous system disorders     
Headache *  3/243 (1.23%)  5/236 (2.12%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Johnson Varughese
Organization: Exec Dir Clinical Dir
Phone: 908-927-1162
EMail: johnson.varughese@valeant.com
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01701024     History of Changes
Other Study ID Numbers: V01-ACYC-301
First Submitted: September 27, 2012
First Posted: October 4, 2012
Results First Submitted: January 15, 2015
Results First Posted: January 10, 2017
Last Update Posted: June 4, 2018