Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Galderma Laboratories, L.P.

ClinicalTrials.gov Identifier:

NCT01139047

First received: June 4, 2010

Last updated: September 21, 2012

Last verified: September 2012

History of Changes

Results First Received: June 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Skin Manifestations
Interventions:	Drug: metronidazole 1% gel Drug: azelaic acid 15% gel

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
Dates of recruitment period: First subject was enrolled on June 7, 2010 and the last subject was enrolled on June 7, 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Wash-out period up to baseline for topical treatment on the treated area was less than 1 week for corticosteroids and/or 4 weeks for retinoids; for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.

Reporting Groups

	Description
MetroGel® 1% and Finacea® Gel 15%	This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks

Participant Flow: Overall Study

	MetroGel® 1% and Finacea® Gel 15%
STARTED	77
COMPLETED	76
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
MetroGel® 1% and Finacea® Gel 15%	This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks

Baseline Measures

	MetroGel® 1% and Finacea® Gel 15%
Number of Participants [units: participants]	77
Age [units: years] Mean ± Standard Deviation	42.4 ± 15.07
Gender [units: participants]
Female	61
Male	16

Outcome Measures

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1. Primary:

Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3 [ Time Frame: baseline to week 3 ]

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2. Secondary:

Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22 [ Time Frame: day 22 ]

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3. Secondary:

6 Question Subject Preference Survey at Week 3 [ Time Frame: 3 weeks ]

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Measure Type	Secondary
Measure Title	6 Question Subject Preference Survey at Week 3
Measure Description	Number of participants per response to each question of the subject preference survey at week 3
Time Frame	3 weeks
Safety Issue	No

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.
Safety

Reporting Groups

	Description
MetroGel® 1% and Finacea Gel® 15%	This was a randomized split-face study where metronidazole 1% gel was applied to one side of the face once daily for 3 weeks and azelaic acid 15 % gel was applied to the opposite side of the face twice daily for 3 weeks

Measured Values

	MetroGel® 1% and Finacea Gel® 15%
Number of Participants Analyzed [units: participants]	77
6 Question Subject Preference Survey at Week 3 [units: participants]
1. Side of face felt better MetroGel®	21
1. Side of face felt better Finacea®	14
1. Side of face both felt same	30
1. Side of face neither felt better	12
1. Side of face felt better Missing	0
2. Overall impression of MetroGel® Very pleasant	3
2. Overall impression of MetroGel® Pleasant	36
2. Overall impression of MetroGel® Okay	34
2. Overall impression of MetroGel® Unpleasant	4
2. Overall impression of MetroGel® Very unpleasant	0
2. Overall impression of MetroGel® Missing	0
3. Overall impression of Finacea® Very pleasant	5
3. Overall impression of Finacea® Pleasant	26
3. Overall impression of Finacea® Okay	38
3. Overall impression of Finacea® Unpleasant	5
3. Overall impression of Finacea® Very unpleasant	3
3. Overall impression of Finacea® Missing	0
4. Side of face more sensitive MetroGel®	4
4. Side of face more sensitive Finacea®	32
4. Side of face more sensitive both felt same	12
4. Side of face more sensitive Neither	29
4. Side of face more sensitive Missing	0
5. Which side was easier to use MetroGel®?	13
5. Which side was easier to use Finacea®?	13
5. Which side was easier to use both equal?	50
5. Which side was easier to use Neither?	1
5. Which side was easier to use Missing	0
6. Which product tell a friend about MetroGel®?	13
6. Which product tell a friend about Finacea®?	11
6. Which product tell a friend about Both?	32
6. Which product tell a friend about Neither?	21
6. Which product tell a friend about Missing?	0

No statistical analysis provided for 6 Question Subject Preference Survey at Week 3

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: The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.

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.

Results Point of Contact:

Name/Title: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
phone: 817-961-5358
e-mail: ron.gottschalk@galderma.com

No publications provided

Responsible Party:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT01139047 History of Changes
Other Study ID Numbers:	US10160
Study First Received:	June 4, 2010
Results First Received:	June 28, 2011
Last Updated:	September 21, 2012
Health Authority:	United States: Institutional Review Board

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