Study STF115288, a Clinical Confirmation Study of GI148512 in the Treatment of Acne Vulgaris in Japanese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01400932
First received: July 21, 2011
Last updated: July 10, 2014
Last verified: May 2012
Results First Received: July 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: GI148512
Drug: vehicle gel

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GI148512 Participants applied 2 finger tip units (FTU) of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Vehicle Gel Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.

Participant Flow:   Overall Study
    GI148512     Vehicle Gel  
STARTED     178     182  
COMPLETED     164     167  
NOT COMPLETED     14     15  
Adverse Event                 10                 5  
Lack of Efficacy                 0                 3  
Withdrawal by Subject                 2                 6  
Lost to Follow-up                 1                 0  
Protocol Deviation                 0                 1  
Met Protocol-defined Stopping Criteria                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GI148512 Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Vehicle Gel Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
Total Total of all reporting groups

Baseline Measures
    GI148512     Vehicle Gel     Total  
Number of Participants  
[units: participants]
  178     182     360  
Age  
[units: Years]
Mean ± Standard Deviation
  21.3  ± 5.93     22.4  ± 6.76     21.9  ± 6.38  
Gender  
[units: Participants]
     
Female     118     116     234  
Male     60     66     126  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian-Japanese Heritage     178     182     360  
Total Lesion Counts at Baseline [1]
[units: lesion counts]
Mean ± Standard Deviation
  72.1  ± 33.40     70.3  ± 30.89     71.2  ± 32.12  
Non-inflammatory Lesion (NIL) Counts at Baseline [2]
[units: lesion counts]
Mean ± Standard Deviation
  44.2  ± 28.03     42.7  ± 26.28     43.4  ± 27.14  
Inflammatory Lesion (IL) Counts at Baseline [3]
[units: lesion counts]
Mean ± Standard Deviation
  28.0  ± 10.76     27.5  ± 10.09     27.7  ± 10.41  
Participants with the Indicated Investigational's Static Global Assessment (ISGA) Score at Baseline [4]
[units: participants]
     
0: Clear     0     0     0  
1: Almost Clear     0     0     0  
2: Mild Severity     41     45     86  
3: Moderate Severity     117     118     235  
4: Severe     20     19     39  
5: Very Severe     0     0     0  
[1] The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit.
[2] The investigator/subinvestigator counted all non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color.
[3] The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions [NL]) on the face at each study visit. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.
[4] Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no NLs); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change in Total Lesion Counts From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8   [ Time Frame: Baseline; Weeks 1, 2, 4, and 8 ]

3.  Secondary:   Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ]

4.  Secondary:   Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline; Weeks 1, 2, 4 and 8 and 12 ]

5.  Secondary:   Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator’s Static Global Assessment (ISGA) Score From Baseline to Week 12   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12   [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]

7.  Secondary:   Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12   [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ]

8.  Secondary:   Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal   [ Time Frame: Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal ]

9.  Secondary:   Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal   [ Time Frame: Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01400932     History of Changes
Other Study ID Numbers: 115288
Study First Received: July 21, 2011
Results First Received: July 10, 2014
Last Updated: July 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency