Adjunctive Usage of a Moisturizing Lotion (Cetaphil® Moisturizing Lotion) to Limit the Skin Irritation Linked to the Set-Up of a Treatment by Topical Retinoid (Differin® Gel 0,1%) in Healthy Subjects of Chinese Origins

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Galderma

ClinicalTrials.gov Identifier:

NCT00971282

First received: September 2, 2009

Last updated: April 16, 2012

Last verified: April 2012

History of Changes

Results First Received: August 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Single Blind (Investigator); Primary Purpose: Prevention
Condition:	Healthy Skin
Interventions:	Drug: adapalen 0.1% Other: Cetaphil®

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
Intra-individual Comparison	Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face

Participant Flow: Overall Study

	Intra-individual Comparison
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Intra-individual Comparison	Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face

Baseline Measures

	Intra-individual Comparison
Number of Participants [units: participants]	30
Age [units: participants]
<=18 years	0
Between 18 and 65 years	30
>=65 years	0
Age [units: years] Mean ± Standard Deviation	39.9 ± 11.8
Gender [units: participants]
Female	20
Male	10
Region of Enrollment [units: participants]
Singapore	30

Outcome Measures

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1. Primary:

Erythema Rating Scale [ Time Frame: at 4 weeks ]

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2. Primary:

Scaling [ Time Frame: at 4 weeks ]

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3. Primary:

Dryness [ Time Frame: at 4 weeks ]

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4. Primary:

Stinging/Burning [ Time Frame: at 4 weeks ]

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5. Primary:

Pruritus [ Time Frame: at 4 weeks ]

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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 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.

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: Florence Paliargues
Organization: Galderma
phone: 0033 4 92 95 29 57
e-mail: Florence.Paliargues@Galderma.com

No publications provided

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT00971282 History of Changes
Other Study ID Numbers:	RD.03.SPR.29076
Study First Received:	September 2, 2009
Results First Received:	August 31, 2011
Last Updated:	April 16, 2012
Health Authority:	Singapore: Health Sciences Authority

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