Trial Outcomes & Findings for Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin (NCT NCT01046565)

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

75 participants

Primary outcome timeframe

baseline to week 3

Results posted on

2022-08-25

Participant Flow

Dates of recruitment period: First subject was enrolled on January 11, 2010 and the last subject was enrolled on January 11, 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® Lotion 0.1% and Differin® Cream 0.1% Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream - apply topically to the opposite site of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
Overall Study STARTED	75
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Differin® Lotion 0.1% and Differin® Cream 0.1% Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream - apply topically to the opposite site of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Differin® Lotion 0.1% and Differin Cream 0.1% n=75 Participants Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
Age, Continuous	44.75 years STANDARD_DEVIATION 13.39 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants
Sex: Female, Male Male	16 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® Lotion 0.1% n=66 Participants Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.	Differin Cream 0.1% n=66 Participants Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.	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. Erythema	35 participants	33 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. Scaling	58 participants	61 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	46 participants	44 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	57 participants	60 participants	—

SECONDARY outcome

Timeframe: week 3

Population: ITT (Intent to Treat)

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

Outcome measures

Outcome measures
Measure	Differin® Lotion 0.1% n=75 Participants Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.	Differin Cream 0.1% n=75 Participants Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.	No Preference n=75 Participants Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
6 Question Subject Cosmetic Acceptability Questionnaire Which side was easier to apply?	17 participants	14 participants	44 participants
6 Question Subject Cosmetic Acceptability Questionnaire Which side absorbed into your skin more quickly?	25 participants	23 participants	27 participants
6 Question Subject Cosmetic Acceptability Questionnaire Which side had less odor?	7 participants	4 participants	64 participants
6 Question Subject Cosmetic Acceptability Questionnaire Which side felt better on your skin?	27 participants	22 participants	26 participants
6 Question Subject Cosmetic Acceptability Questionnaire Which side left less residue on your skin?	15 participants	22 participants	38 participants
6 Question Subject Cosmetic Acceptability Questionnaire Generally, which side did you prefer?	26 participants	23 participants	26 participants

Adverse Events

Differin® Lotion 0.1%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Differin Cream 0.1%

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