Trial Outcomes & Findings for Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin (NCT NCT01139008)

Last Updated: 2022-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

baseline to week 3

Results posted on

2022-08-01

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	MetroGel® 1% and Finacea 15% 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 Study STARTED	80
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	MetroGel® 1% and Finacea 15% 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 Study Withdrawal by Subject	5
Overall Study Non-compliant, lost product	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MetroGel® 1% and Finacea® Gel 15% n=80 Participants 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
Sex: Female, Male Male	22 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 15.16 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 3

Population: Safety

Outcome measures

Outcome measures
Measure	MetroGel® 1% n=80 Participants metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks	Finacea® Gel 15% n=80 Participants azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
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 Erythema	14 participants	11 participants
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 Scaling	79 participants	78 participants
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 Dryness	71 participants	70 participants
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 Stinging/Burning	72 participants	65 participants

SECONDARY outcome

Timeframe: Day 22

Population: Safety

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.

Outcome measures

Outcome measures
Measure	MetroGel® 1% n=80 Participants metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks	Finacea® Gel 15% n=80 Participants azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
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. Erythema	34 participants	29 participants
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. Scaling	74 participants	73 participants
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. Dryness	73 participants	73 participants
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. Stinging/Burning	72 participants	68 participants

SECONDARY outcome

Timeframe: week 3

Population: Safety

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

Outcome measures

Outcome measures
Measure	MetroGel® 1% n=80 Participants metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks	Finacea® Gel 15% azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
6 Question Subject Preference Survey at Week 3 1. Side of face felt better MetroGel®	16 participants	—
6 Question Subject Preference Survey at Week 3 1. Side of face felt better Finacea®	20 participants	—
6 Question Subject Preference Survey at Week 3 1. Side of face both felt same	31 participants	—
6 Question Subject Preference Survey at Week 3 1. Side of face neither felt better	11 participants	—
6 Question Subject Preference Survey at Week 3 1. Side of face Missing	2 participants	—
6 Question Subject Preference Survey at Week 3 2. Overall impression of MetroGel® Very pleasant	16 participants	—
6 Question Subject Preference Survey at Week 3 2. Overall impression of MetroGel® Pleasant	25 participants	—
6 Question Subject Preference Survey at Week 3 2. Overall impression of MetroGel® Okay	32 participants	—
6 Question Subject Preference Survey at Week 3 2. Overall impression of MetroGel® Unpleasant	3 participants	—
6 Question Subject Preference Survey at Week 3 2. Overall impression of MetroGel® Very Unpleasant	2 participants	—
6 Question Subject Preference Survey at Week 3 2. Overall impression of MetroGel® Missing	2 participants	—
6 Question Subject Preference Survey at Week 3 3. Overall impression of Finacea® Very pleasant	15 participants	—
6 Question Subject Preference Survey at Week 3 3. Overall impression of Finacea® Pleasant	33 participants	—
6 Question Subject Preference Survey at Week 3 3. Overall impression of Finacea® Okay	25 participants	—
6 Question Subject Preference Survey at Week 3 3. Overall impression of Finacea® Unpleasant	4 participants	—
6 Question Subject Preference Survey at Week 3 3. Overall impression of Finacea® Very unpleasant	1 participants	—
6 Question Subject Preference Survey at Week 3 3. Overall impression of Finacea® Missing	2 participants	—
6 Question Subject Preference Survey at Week 3 4. Side of face more sensitive MetroGel®	12 participants	—
6 Question Subject Preference Survey at Week 3 4. Side of face more sensitive Finacea®	27 participants	—
6 Question Subject Preference Survey at Week 3 4. Side of face more sensitive both felt same	10 participants	—
6 Question Subject Preference Survey at Week 3 4. Side of face more sensitive Neither	29 participants	—
6 Question Subject Preference Survey at Week 3 4. Side of face more sensitive Missing	2 participants	—
6 Question Subject Preference Survey at Week 3 5. Which side was easier to use MetroGel®?	18 participants	—
6 Question Subject Preference Survey at Week 3 5. Which side was easier to use Finacea®?	21 participants	—
6 Question Subject Preference Survey at Week 3 5. Which side was easier to use both equal?	38 participants	—
6 Question Subject Preference Survey at Week 3 5. Which side was easier to use Neither?	1 participants	—
6 Question Subject Preference Survey at Week 3 5. Which side was easier to use Missing	2 participants	—
6 Question Subject Preference Survey at Week 3 6. Which product tell a friend about MetroGel®?	16 participants	—
6 Question Subject Preference Survey at Week 3 6. Which product tell a friend about Finacea®?	26 participants	—
6 Question Subject Preference Survey at Week 3 6. Which product tell a friend about Both?	25 participants	—
6 Question Subject Preference Survey at Week 3 6. Which product tell a friend about Neither?	11 participants	—
6 Question Subject Preference Survey at Week 3 6. Which product tell a friend about Missing	2 participants	—

Adverse Events

MetroGel® 1%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Finacea® Gel 15%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronald W. Gottschalk, MD / Medical Director

Galderma Laboratories, L.P.

Phone: 817-961-5358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER