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

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01139008
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.

Condition or Disease	Intervention/Treatment	Phase
Skin Manifestations	Drug: metronidazole 1% gel; Drug: azelaic acid 15% gel	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% Versus Finacea® (Azelaic Acid) Gel 15% in Subjects With Healthy Skin
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: metronidazole 1% gel	Drug: metronidazole 1% gel; Apply topically on one side of the face once daily for three weeks; Other Names: MetroGel® 1%
Active Comparator: azelaic acid 15% gel	Drug: azelaic acid 15% gel; Apply topically on the opposite side of the face twice daily for three weeks; Other Names: Finacea® 15% Gel

Outcome Measures

Primary Outcome Measures

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

   Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.

Secondary Outcome Measures

1. 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. [Day 22]

   Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.

2. 6 Question Subject Preference Survey at Week 3 [week 3]

   Number of participants per response to each question of the Subject Preference Survey at week 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and female adults (ages 18 years or older)

• Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

• Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions

• Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)

• Subjects who have participated in another investigational drug or device research study within 30 days of enrollment

• Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids

• Subjects with a washout period 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

• Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated

• Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas J. Stephens and Associates, Inc.	Carrollton	Texas	United States	75006

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ronald W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01139008
• Other Study ID Numbers: US10159
• First Posted: Jun 8, 2010
• Last Update Posted: Aug 1, 2022
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Skin Manifestations; Metronidazole; Azelaic acid

Study Results

Participant Flow

Recruitment Details	Dates of recruitment period: First subject was enrolled on June 7, 2010 and the last subject was enrolled on June 7, 2010. Types of location: Investigative site was located at a research center.
Pre-assignment Detail	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.

Arm/Group Title	MetroGel® 1% and Finacea 15%
Arm/Group Description	This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
Period Title: Overall Study
STARTED	80
COMPLETED	74
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	MetroGel® 1% and Finacea® Gel 15%
Arm/Group Description	This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
Overall Participants	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (15.16)
Sex: Female, Male (Count of Participants)
Female	58 72.5%
Male	22 27.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3
Description	Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0.
Time Frame	baseline to week 3

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	MetroGel® 1%	Finacea® Gel 15%
Arm/Group Description	metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks	azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
Measure Participants	80	80
Erythema	14 17.5%	11 NaN
Scaling	79 98.8%	78 NaN
Dryness	71 88.8%	70 NaN
Stinging/Burning	72 90%	65 NaN

2. Secondary Outcome

Title	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.
Description	Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment.
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	MetroGel® 1%	Finacea® Gel 15%
Arm/Group Description	metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks	azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
Measure Participants	80	80
Erythema	34 42.5%	29 NaN
Scaling	74 92.5%	73 NaN
Dryness	73 91.3%	73 NaN
Stinging/Burning	72 90%	68 NaN

3. Secondary Outcome

Title	6 Question Subject Preference Survey at Week 3
Description	Number of participants per response to each question of the Subject Preference Survey at week 3
Time Frame	week 3

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	MetroGel® 1% and Finacea® Gel 15%
Arm/Group Description	This is a split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid 15% gel was applied topically to the opposite side of the face twice daily for 3 weeks
Measure Participants	80
1. Side of face felt better MetroGel®	16 20%
1. Side of face felt better Finacea®	20 25%
1. Side of face both felt same	31 38.8%
1. Side of face neither felt better	11 13.8%
1. Side of face Missing	2 2.5%
2. Overall impression of MetroGel® Very pleasant	16 20%
2. Overall impression of MetroGel® Pleasant	25 31.3%
2. Overall impression of MetroGel® Okay	32 40%
2. Overall impression of MetroGel® Unpleasant	3 3.8%
2. Overall impression of MetroGel® Very Unpleasant	2 2.5%
2. Overall impression of MetroGel® Missing	2 2.5%
3. Overall impression of Finacea® Very pleasant	15 18.8%
3. Overall impression of Finacea® Pleasant	33 41.3%
3. Overall impression of Finacea® Okay	25 31.3%
3. Overall impression of Finacea® Unpleasant	4 5%
3. Overall impression of Finacea® Very unpleasant	1 1.3%
3. Overall impression of Finacea® Missing	2 2.5%
4. Side of face more sensitive MetroGel®	12 15%
4. Side of face more sensitive Finacea®	27 33.8%
4. Side of face more sensitive both felt same	10 12.5%
4. Side of face more sensitive Neither	29 36.3%
4. Side of face more sensitive Missing	2 2.5%
5. Which side was easier to use MetroGel®?	18 22.5%
5. Which side was easier to use Finacea®?	21 26.3%
5. Which side was easier to use both equal?	38 47.5%
5. Which side was easier to use Neither?	1 1.3%
5. Which side was easier to use Missing	2 2.5%
6. Which product tell a friend about MetroGel®?	16 20%
6. Which product tell a friend about Finacea®?	26 32.5%
6. Which product tell a friend about Both?	25 31.3%
6. Which product tell a friend about Neither?	11 13.8%
6. Which product tell a friend about Missing	2 2.5%

Adverse Events

Time Frame	3 weeks
Adverse Event Reporting Description	Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
Arm/Group Title	MetroGel® 1%		Finacea® Gel 15%
Arm/Group Description	metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks		azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
All Cause Mortality
	MetroGel® 1%		Finacea® Gel 15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MetroGel® 1%		Finacea® Gel 15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/80 (0%)
Other (Not Including Serious) Adverse Events
	MetroGel® 1%		Finacea® Gel 15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/80 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.