A Study of Acne Treatment in Children Ages 9 to 11

This study has been completed.

Study NCT00907335 Information provided by Johnson & Johnson Consumer & Personal Products Worldwide

First Received on May 20, 2009. Last Updated on October 4, 2011 History of Changes

Results First Received: November 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Interventions:	Drug: Retin-A Micro 0.04% facial acne treatment Drug: Vehicle control

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
Retin-A Micro	Retin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control	Color matched facial gel vehicle control used once daily

Participant Flow: Overall Study

	Retin-A Micro	Vehicle Control
STARTED	55	55
COMPLETED	47	54
NOT COMPLETED	8	1
Withdrawal by Subject	2	0
Adverse Event	4	1
Lost to Follow-up	2	0

Baseline Characteristics

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Reporting Groups

	Description
Retin-A Micro	Retin-A Micro 0.04% facial acne treatment used once daily
Vehicle Control	Color matched facial gel vehicle control used once daily

Baseline Measures

	Retin-A Micro	Vehicle Control	Total
Number of Participants [units: participants]	55	55	110
Age, Customized [units: participants]
9 years	5	4	9
10 Years	21	17	38
11 Years	29	34	63
Gender [units: participants]
Female	44	38	82
Male	11	17	28
Region of Enrollment [units: participants]
United States	55	55	110
Subject Reached Puberty [units: Participants]
Yes	17	21	38
No	38	34	72
Fitzpatrick Score ^[1] [units: Participants]
I	2	1	3
II	17	12	29
III	11	16	27
IV	14	15	29
V	8	9	17
VI	3	2	5

[1]	Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI).

Outcome Measures

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1. Primary:

Change From Baseline in Total Non-inflammatory Lesion Count [ Time Frame: Baseline to Week 12 ]

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2. Secondary:

Change From Baseline in Lesion Counts [ Time Frame: Baseline to Week 12 ]

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3. Secondary:

Measurement of Success 1 [ Time Frame: Week 12 ]

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4. Secondary:

Measurement of Success 2 [ Time Frame: Week 12 ]

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5. Secondary:

Measurement of Success 3 [ Time Frame: Week 12 ]

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6. Secondary:

Global Assessment [ Time Frame: Baseline 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.

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: Joyce Hauze, Senior Specialist, Clinical Research Operations
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com

No publications provided

Responsible Party:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00907335 History of Changes
Other Study ID Numbers:	CA-P-6397
Study First Received:	May 20, 2009
Results First Received:	November 30, 2010
Last Updated:	October 4, 2011
Health Authority:	United States: Food and Drug Administration