Trial Outcomes & Findings for Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin (NCT NCT01046396)

Results Overview

Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to 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 for each category was defined as a tolerability score of 0.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

69 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 January 11, 2010 and the last subject was enrolled on January 13, 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, it was less than 1 week for medications that may have increased photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.

Participant milestones

Participant milestones
Measure	Differin® Cream 0.1% and Differin® Lotion 0.1% Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
Overall Study STARTED	69
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Differin® Cream 0.1% and Differin® Lotion 0.1% Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Differin® Cream 0.1% and Differin® Lotion 0.1% n=69 Participants Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
Age, Continuous	38.87 years STANDARD_DEVIATION 13.43 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 3

Population: Per protocol

Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to 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 for each category was defined as a tolerability score of 0.

Outcome measures

Outcome measures
Measure	Differin® Cream 0.1% n=64 Participants Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks	Differin® Lotion 0.1% n=64 Participants Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks	No Preference Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. Scaling	32 participants	30 participants	—
Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. Erythema	9 participants	9 participants	—
Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. Dryness	14 participants	14 participants	—
Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. Stinging / Burning	58 participants	56 participants	—

SECONDARY outcome

Timeframe: week 3

Population: ITT (Intent to Treat)

Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3.

Outcome measures

Outcome measures
Measure	Differin® Cream 0.1% n=69 Participants Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks	Differin® Lotion 0.1% n=69 Participants Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks	No Preference n=69 Participants Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 Generally, which side did you prefer?	23 participants	13 participants	28 participants
6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 Which side was easier to apply?	19 participants	12 participants	33 participants
6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 Which side absorbed into your skin more quickly?	27 participants	17 participants	20 participants
6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 Which side had less odor?	7 participants	10 participants	47 participants
6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 Which side felt better on your skin?	26 participants	15 participants	23 participants
6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 Which side left less residue on your skin?	18 participants	15 participants	31 participants

Adverse Events

Differin® Cream 0.1%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Differin® Lotion 0.1%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Differin® Cream 0.1% n=69 participants at risk Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks	Differin® Lotion 0.1% n=69 participants at risk Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
Infections and infestations head cold	7.2% 5/69 • Number of events 5 • 3 weeks Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.	7.2% 5/69 • Number of events 5 • 3 weeks Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), when applicable.

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