Trial Outcomes & Findings for Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1% (NCT NCT00660985)

Results Overview

the observed peak drug (adapalene) concentration

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

Results posted on

2021-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	Differin® Gel, 0.3% Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% Gel, 0.1%, 2g, once daily for 30 days
Overall Study STARTED	26	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Differin® Gel, 0.3% n=26 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 Participants Gel, 0.1%, 2g, once daily for 30 days	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	23.4 years STANDARD_DEVIATION 4.87 • n=5 Participants	21.3 years STANDARD_DEVIATION 3.78 • n=7 Participants	22.4 years STANDARD_DEVIATION 4.46 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	25 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

the observed peak drug (adapalene) concentration

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=25 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 Participants Gel, 0.1%, 2g, once daily for 30 days
Cmax (ng/mL) at Day 1	0.10 ng/mL Standard Deviation 0.10	0.02 ng/mL Standard Deviation 0.06

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

the observed peak drug (adapalene) concentration

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=25 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 Participants Gel, 0.1%, 2g, once daily for 30 days
Cmax (ng/mL) at Day 15	0.18 ng/mL Standard Deviation 0.09	0.04 ng/mL Standard Deviation 0.08

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose)

the observed peak drug (adapalene) concentration

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=25 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 Participants Gel, 0.1%, 2g, once daily for 30 days
Cmax (ng/mL) at Day 30	0.15 ng/mL Standard Deviation 0.10	0.03 ng/mL Standard Deviation 0.06

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

Population: 26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 14 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 1.

the time at which Cmax occurs

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=14 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=4 Participants Gel, 0.1%, 2g, once daily for 30 days
Tmax (hr) at Day 1	15 hours Standard Deviation 6	11 hours Standard Deviation 4

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

Population: 26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 23 subjects in the Differin Gel 0.3% and 7 subjects in the Differin Gel 0.1% were detectable at Day 15.

the time at which Cmax occurs

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=23 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=7 Participants Gel, 0.1%, 2g, once daily for 30 days
Tmax (hr) at Day 15	13 hours Standard Deviation 8	11 hours Standard Deviation 5

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)

Population: 26 subjects in the Differin Gel 0.3% and 25 subjects in the Differin Gel 0.1% were included in the study. 20 subjects in the Differin Gel 0.3% and 4 subjects in the Differin Gel 0.1% were detectable at Day 30.

the time at which Cmax occurs

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=20 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=4 Participants Gel, 0.1%, 2g, once daily for 30 days
Tmax (hr) at Day 30	13 hours Standard Deviation 6	12 hours Standard Deviation 3

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24 hr (corresponding to the dosing interval)

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=25 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 Participants Gel, 0.1%, 2g, once daily for 30 days
Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24))	1.54 ng*h/mL Standard Deviation 1.58	0.31 ng*h/mL Standard Deviation 0.73

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose)

area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=24 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 Participants Gel, 0.1%, 2g, once daily for 30 days
Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24))	2.84 ng*h/mL Standard Deviation 1.75	0.50 ng*h/mL Standard Deviation 0.99

PRIMARY outcome

Timeframe: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose)

area under the concentration-time curve calculated mixed linear-logarithmic trapezoidal method from pre-application (T0) through 24hr (corresponding to the dosing interval)

Outcome measures

Outcome measures
Measure	Differin® Gel, 0.3% n=25 Participants Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 Participants Gel, 0.1%, 2g, once daily for 30 days
Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24))	2.64 ng*h/mL Standard Deviation 1.66	0.42 ng*h/mL Standard Deviation 1.03

Adverse Events

Differin® Gel, 0.3%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Differin® Gel, 0.1%

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Differin® Gel, 0.3% n=26 participants at risk Gel, 0.3%, 2g, once daily for 30 days	Differin® Gel, 0.1% n=25 participants at risk Gel, 0.1%, 2g, once daily for 30 days
Injury, poisoning and procedural complications Joint sprain	7.7% 2/26 • Number of events 2	0.00% 0/25
Skin and subcutaneous tissue disorders Skin irritation	3.8% 1/26 • Number of events 1	8.0% 2/25 • Number of events 2

Additional Information

Michael Graeber, MD, Head of Global Clinical Project Management and US Development

Galderma

Phone: 609-860-8201

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place