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Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT01628549
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : January 8, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: 50 mg P005672-HCl
Drug: Placebo
Drug: 100 mg P005672-HCl
Enrollment 285
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description Two placebo capsules matching P005672-HCl, taken orally each day One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day Two P005672-HCl 50 mg capsules, taken orally each day Two P005672-HCl 100 mg capsules, taken orally each day
Period Title: Overall Study
Started 73 76 70 66
Completed 64 64 60 57
Not Completed 9 12 10 9
Reason Not Completed
Adverse Event             1             1             0             4
Lost to Follow-up             3             4             3             3
Withdrawal by Subject             3             4             4             1
Protocol Violation             2             1             1             0
withdrawn for noncompliance             0             2             1             0
abnormal laboratory test results             0             0             1             0
positive pregnancy test             0             0             0             1
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day Total
Hide Arm/Group Description Two placebo capsules matching P005672-HCl, taken orally each day One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day Two P005672-HCl 50 mg capsules, taken orally each day Two P005672-HCl 100 mg capsules, taken orally each day Total of all reporting groups
Overall Number of Baseline Participants 73 76 70 66 285
Hide Baseline Analysis Population Description
285 participants were randomized to double-blind treatment (Safety population)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 76 participants 70 participants 66 participants 285 participants
20.8  (6.99) 19.7  (5.92) 19.9  (7.04) 20.3  (7.11) 20.2  (6.74)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 76 participants 70 participants 66 participants 285 participants
Male
25
  34.2%
29
  38.2%
30
  42.9%
29
  43.9%
113
  39.6%
Female
48
  65.8%
47
  61.8%
40
  57.1%
37
  56.1%
172
  60.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 76 participants 70 participants 66 participants 285 participants
Hispanic or Latino 19 21 16 19 75
Not Hispanic or Latino 54 55 54 47 210
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 76 participants 70 participants 66 participants 285 participants
American Indian or Alaska Native 1 0 0 1 2
Asian 4 4 3 1 12
Black or African American 17 18 21 13 69
Native Hawaiian or Other Pacific islander 0 0 0 0 0
White 54 55 46 52 207
[1]
Measure Analysis Population Description: Five subjects in the Safety Population checked multiple races.
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 73 participants 76 participants 70 participants 66 participants 285 participants
165.80  (10.436) 167.49  (9.047) 167.23  (7.380) 167.33  (9.764) 166.96  (9.206)
Weight at Baseline  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 73 participants 76 participants 70 participants 66 participants 285 participants
68.47  (10.306) 66.37  (8.749) 69.69  (11.861) 67.31  (9.486) 67.94  (10.173)
1.Primary Outcome
Title The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Hide Description [Not Specified]
Time Frame Baseline (Week 0) to Final Visit (Up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population.
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description:
Two placebo capsules matching P005672-HCl, taken orally each day
One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
Two P005672-HCl 50 mg capsules, taken orally each day
Two P005672-HCl 100 mg capsules, taken orally each day
Overall Number of Participants Analyzed 72 76 70 66
Mean (Standard Deviation)
Unit of Measure: Number of Inflammatory Lesions
12.8  (14.18) 14.4  (13.01) 17.6  (16.65) 17.1  (11.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, P005672-HCl Approximately 0.75 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4344
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
-2.32 to 5.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, P005672-HCl Approximately 1.5 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0266
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value 4.46
Confidence Interval (2-Sided) 95%
0.52 to 8.40
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, P005672-HCl Approximately 3.0 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0317
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value 4.37
Confidence Interval (2-Sided) 95%
0.39 to 8.36
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
Hide Description

The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.

The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

Time Frame Final Visit (Up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description:
Two placebo capsules matching P005672-HCl, taken orally each day
One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
Two P005672-HCl 50 mg capsules, taken orally each day
Two P005672-HCl 100 mg capsules, taken orally each day
Overall Number of Participants Analyzed 72 76 70 66
Measure Type: Count of Participants
Unit of Measure: Participants
Success
8
  11.1%
11
  14.5%
17
  24.3%
10
  15.2%
Failure
64
  88.9%
65
  85.5%
53
  75.7%
56
  84.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, P005672-HCl Approximately 0.75 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3300
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference vs placebo in success rate
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
-7.82 to 14.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, P005672-HCl Approximately 1.5 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0159
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference vs placebo in success rate
Estimated Value 13.2
Confidence Interval (2-Sided) 95%
0.54 to 25.60
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, P005672-HCl Approximately 3.0 mg/kg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4834
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference vs placebo in success rate
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-7.44 to 15.87
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Hide Description [Not Specified]
Time Frame Baseline (Week 0) up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description:
Two placebo capsules matching P005672-HCl, taken orally each day
One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
Two P005672-HCl 50 mg capsules, taken orally each day
Two P005672-HCl 100 mg capsules, taken orally each day
Overall Number of Participants Analyzed 72 76 70 66
Mean (Standard Deviation)
Unit of Measure: Count of Inflammatory Lesions
Change from Baseline at Week 1 5.8  (9.07) 5.4  (9.28) 5.4  (8.44) 5.9  (8.33)
Change from Baseline at Week 2 8.4  (10.13) 8.5  (10.02) 8.2  (14.45) 9.7  (11.30)
Change from Baseline at Week 4 10.9  (10.04) 9.3  (13.84) 11.7  (15.36) 12.8  (9.96)
Change from Baseline at Week 8 12.6  (12.57) 13.1  (11.89) 15.0  (16.66) 14.3  (12.90)
Change from Baseline at Week 12 12.8  (14.18) 14.3  (13.00) 17.6  (16.65) 17.1  (11.69)
Change from Baseline at Final Visit(Up to Week 12) 12.8  (14.18) 14.4  (13.01) 17.6  (16.65) 17.1  (11.69)
4.Secondary Outcome
Title The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Hide Description [Not Specified]
Time Frame Baseline (Week 0) up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description:
Two placebo capsules matching P005672-HCl, taken orally each day
One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
Two P005672-HCl 50 mg capsules, taken orally each day
Two P005672-HCl 100 mg capsules, taken orally each day
Overall Number of Participants Analyzed 72 76 70 66
Mean (Standard Deviation)
Unit of Measure: Count of Noninflammatory Lesions
Change from Baseline at Week 1 5.4  (12.99) 3.8  (14.28) 4.3  (14.10) 5.1  (13.83)
Change from Baseline at Week 2 10.6  (16.02) 9.4  (13.58) 7.8  (16.92) 7.9  (14.24)
Change from Baseline at Week 4 13.0  (24.17) 10.0  (17.25) 9.9  (20.58) 12.7  (15.24)
Change from Baseline at Week 8 16.9  (22.52) 14.3  (21.44) 14.0  (22.22) 15.2  (19.04)
Change from Baseline at Week 12 17.8  (21.63) 17.9  (19.85) 19.1  (22.33) 17.0  (21.56)
Change from Baseline at Final Visit(Up to Week 12) 17.8  (21.63) 17.9  (19.83) 19.1  (22.33) 17.0  (21.56)
5.Secondary Outcome
Title The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Hide Description [Not Specified]
Time Frame Baseline (Week 0) up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description:
Two placebo capsules matching P005672-HCl, taken orally each day
One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
Two P005672-HCl 50 mg capsules, taken orally each day
Two P005672-HCl 100 mg capsules, taken orally each day
Overall Number of Participants Analyzed 72 76 70 66
Mean (Standard Deviation)
Unit of Measure: Percent Change - Inflammatory Lesions
Change from Baseline at Week 1 19.3  (27.82) 17.2  (28.43) 17.8  (26.39) 19.4  (26.17)
Change from Baseline at Week 2 25.6  (29.02) 26.4  (32.60) 25.8  (36.16) 30.6  (35.88)
Change from Baseline at Week 4 34.1  (28.84) 29.3  (38.90) 34.1  (35.27) 40.0  (31.83)
Change from Baseline at Week 8 37.9  (35.60) 39.8  (34.47) 44.3  (37.99) 44.5  (37.62)
Change from Baseline at Week 12 39.1  (43.00) 43.3  (39.70) 53.6  (37.65) 53.5  (35.18)
Change from Baseline at Final Visit(Up to Week 12) 39.1  (43.00) 43.5  (39.72) 53.6  (37.65) 53.5  (35.18)
6.Secondary Outcome
Title The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Hide Description [Not Specified]
Time Frame Baseline (Week 0) up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description:
Two placebo capsules matching P005672-HCl, taken orally each day
One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
Two P005672-HCl 50 mg capsules, taken orally each day
Two P005672-HCl 100 mg capsules, taken orally each day
Overall Number of Participants Analyzed 72 76 70 66
Mean (Standard Deviation)
Unit of Measure: Percent change - noninflammatory lesions
Change from Baseline at Week 1 9.7  (24.07) 7.7  (26.87) 8.3  (25.20) 10.6  (25.63)
Change from Baseline at Week 2 19.0  (28.36) 16.7  (24.99) 14.6  (30.57) 16.0  (30.37)
Change from Baseline at Week 4 25.0  (37.78) 18.3  (33.17) 19.2  (35.60) 25.7  (29.27)
Change from Baseline at Week 8 30.5  (40.69) 26.1  (38.84) 27.5  (38.54) 30.4  (38.45)
Change from Baseline at Week 12 35.3  (35.32) 34.3  (36.40) 37.2  (38.44) 32.8  (42.59)
Change from Baseline at Final Visit(Up to Week 12) 35.3  (35.32) 34.1  (36.28) 37.2  (38.44) 32.8  (42.59)
7.Secondary Outcome
Title The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
Hide Description

The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.

The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.

Time Frame Baseline to Final Visit (Up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description:
Two placebo capsules matching P005672-HCl, taken orally each day
One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day
Two P005672-HCl 50 mg capsules, taken orally each day
Two P005672-HCl 100 mg capsules, taken orally each day
Overall Number of Participants Analyzed 72 76 70 66
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Success
0
   0.0%
3
   3.9%
0
   0.0%
1
   1.5%
Failure
72
 100.0%
73
  96.1%
70
 100.0%
65
  98.5%
Week 2 Success
2
   2.8%
3
   3.9%
2
   2.9%
2
   3.0%
Failure
70
  97.2%
73
  96.1%
68
  97.1%
64
  97.0%
Week 4 Success
1
   1.4%
2
   2.6%
0
   0.0%
4
   6.1%
Failure
71
  98.6%
74
  97.4%
70
 100.0%
62
  93.9%
Week 8 Success
6
   8.3%
6
   7.9%
8
  11.4%
11
  16.7%
Failure
66
  91.7%
70
  92.1%
62
  88.6%
55
  83.3%
Week 12 Success
8
  11.1%
11
  14.5%
17
  24.3%
10
  15.2%
Failure
64
  88.9%
65
  85.5%
53
  75.7%
56
  84.8%
Final Visit (Up to Week 12) Success
8
  11.1%
11
  14.5%
17
  24.3%
10
  15.2%
Failure
64
  88.9%
65
  85.5%
53
  75.7%
56
  84.8%
Time Frame From Screening (up to week -12) to Week 12 plus 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Hide Arm/Group Description Two placebo capsules matching P005672-HCl, taken orally each day One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day Two P005672-HCl 50 mg capsules, taken orally each day Two P005672-HCl 100 mg capsules, taken orally each day
All-Cause Mortality
Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)   0/76 (0.00%)   0/70 (0.00%)   0/66 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo P005672-HCl Approximately 0.75 mg/kg/Day P005672-HCl Approximately 1.5 mg/kg/Day P005672-HCl Approximately 3.0 mg/kg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/73 (17.81%)   15/76 (19.74%)   8/70 (11.43%)   7/66 (10.61%) 
Gastrointestinal disorders         
Nausea  1  4/73 (5.48%)  6/76 (7.89%)  1/70 (1.43%)  2/66 (3.03%) 
Infections and infestations         
Nasopharyngitis  1  5/73 (6.85%)  4/76 (5.26%)  2/70 (2.86%)  2/66 (3.03%) 
Nervous system disorders         
Headache  1  8/73 (10.96%)  5/76 (6.58%)  5/70 (7.14%)  4/66 (6.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The data obtained in this study are the property of the Sponsor, any manuscript or other presentation of data must first be reviewed by the Sponsor before its submission.
Results Point of Contact
Name/Title: Thearpeutic Area Head
Organization: Allergan
Phone: 714-246-4500
Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01628549     History of Changes
Other Study ID Numbers: PR-10411
First Submitted: June 22, 2012
First Posted: June 26, 2012
Results First Submitted: December 18, 2018
Results First Posted: January 8, 2019
Last Update Posted: February 1, 2019