A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

GlaxoSmithKline ( Stiefel, a GSK Company )

ClinicalTrials.gov Identifier:

NCT01017120

First received: November 19, 2009

Last updated: May 31, 2012

Last verified: May 2012

History of Changes

Results First Received: May 31, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Tazarotene Foam Drug: Vehicle Foam

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tazarotene Foam	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Vehicle Foam	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.

Participant Flow: Overall Study

	Tazarotene Foam	Vehicle Foam
STARTED	373	369
COMPLETED	307	334
NOT COMPLETED	66	35
Adverse Event	9	0
Lost to Follow-up	13	11
Lack of Efficacy	1	0
Withdrawal by Subject	39	21
Pregnancy	1	1
Did Not Meet Eligibility Criteria	1	0
Relocated Out of Town	0	2
Protocol Violation	1	0
Parent Unable to Provide Transportation	1	0

Baseline Characteristics

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Reporting Groups

	Description
Tazarotene Foam	Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Vehicle Foam	The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
Total	Total of all reporting groups

Baseline Measures

	Tazarotene Foam	Vehicle Foam	Total
Number of Participants [units: participants]	373	369	742
Age [units: Years] Mean ± Standard Deviation
Years	19.2 ± 6.5	19.2 ± 6.8	19.2 ± 6.6
Gender [units: Participants]
Female	197	185	382
Male	176	184	360
Race/Ethnicity, Customized [units: participants]
American Indian or Alaskan Native	2	2	4
Asian	28	21	49
Black	60	57	117
Native Hawaiian or Other Pacific Islander	0	4	4
White	278	280	558
Mixed Race	5	5	10

Outcome Measures

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1. Primary:

Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 [ Time Frame: Baseline (Week 0/Day 1) and Week 12 ]

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2. Primary:

Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12 [ Time Frame: Baseline (Week 0/Day 1) and Week 12 ]

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3. Primary:

Number of Participants With an ISGA Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]

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4. Secondary:

Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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5. Secondary:

Absolute Change From Baseline in LC at Weeks 2, 4, and 8 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8 ]

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6. Secondary:

Time to a 50 Percent Reduction in Total Lesion Counts (TLC) [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

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7. Secondary:

Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8 ]

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8. Secondary:

Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 [ Time Frame: Weeks 2, 4, and 8 ]

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9. Secondary:

Number of Participants With a Subject’s Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 [ Time Frame: Weeks 2, 4, 8, and 12 ]

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10. Secondary:

Number of Participants With a 2-G Improvement in ISGA Score and an ISGA Score of 0 or 1 at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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11. Secondary:

Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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12. Secondary:

Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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13. Secondary:

Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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14. Secondary:

Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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15. Secondary:

Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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16. Secondary:

Change in Dermatology Life Quality Index (DLQI) Score From Baseline at Weeks 2, 4, 8, and 12 in Participants 17 Years of Age or Older [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ]

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17. Secondary:

Change in Children’s Dermatology Life Quality Index (CDLQI) From Baseline at Week 2, 4, 8 and 12 in Participant's With 16 Years Old or Younger [ Time Frame: Baseline (Week 0/Day 1); Week 2, 4, 8, and 12 ]

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18. Secondary:

Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

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19. Secondary:

Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

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20. Secondary:

Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

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21. Secondary:

Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

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22. Secondary:

Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:	NCT01017120 History of Changes
Other Study ID Numbers:	114576, W0260-302
Study First Received:	November 19, 2009
Results First Received:	May 31, 2012
Last Updated:	May 31, 2012
Health Authority:	United States: Food and Drug Administration

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