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

This study has been completed.

Study NCT00660985 Information provided by Galderma

First Received on April 15, 2008. Last Updated on January 19, 2011 History of Changes

Results First Received: October 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Acne Vulgaris
Intervention:	Drug: Adapalene

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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

Participant Flow: Overall Study

	Differin® Gel, 0.3%	Differin® Gel, 0.1%
STARTED	26	25
COMPLETED	25	25
NOT COMPLETED	1	0

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Differin® Gel, 0.3%	Differin® Gel, 0.1%	Total
Number of Participants [units: participants]	26	25	51
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	26	25	51
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	23.4 ± 4.87	21.3 ± 3.78	22.4 ± 4.46
Gender [units: participants]
Female	17	14	31
Male	9	11	20
Region of Enrollment [units: participants]
United States	26	25	51

Outcome Measures

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1. Primary:

Cmax (ng/mL) at Day 1 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ]

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2. Primary:

Cmax (ng/mL) at Day 15 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ]

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3. Primary:

Cmax (ng/mL) at Day 30 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T 72hr (post dose) ]

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4. Primary:

Tmax (hr) at Day 1 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ]

Show Outcome Measure 4

5. Primary:

Tmax (hr) at Day 15 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ]

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6. Primary:

Tmax (hr) at Day 30 [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose) ]

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7. Primary:

Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 1 (AUC (0-24)) [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ]

Show Outcome Measure 7

8. Primary:

Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 15 (AUC (0-24)) [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr (post dose) ]

Show Outcome Measure 8

9. Primary:

Area Under the Plasma Concentration Versus Time Curve for 0 to 24 Hours Post Dose Measured on Day 30 (AUC (0-24)) [ Time Frame: T0 (predose), T1hour (hr), T2hr, T4hr, T6 hr, T8 hr, T10hr, T12hr, T16hr, T24hr, T32hr, T36hr, T48hr, T72hr (post dose) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Michael Graeber, MD, Head of Global Clinical Project Management and US Development
Organization: Galderma
phone: 609-860-8201
e-mail: michael.graeber@galderma.com

No publications provided

Responsible Party:	Michael Graeber, MD, Head of US Development:, Galderma R&D
ClinicalTrials.gov Identifier:	NCT00660985 History of Changes
Other Study ID Numbers:	RD.06.SPR.18115
Study First Received:	April 15, 2008
Results First Received:	October 15, 2009
Last Updated:	January 19, 2011
Health Authority:	United States: Food and Drug Administration