Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage

This study has been completed.

Study NCT00647556 Information provided by Galderma Laboratories, L.P.

First Received on March 26, 2008. Last Updated on March 16, 2011 History of Changes

Results First Received: January 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Solar Elastosis
Interventions:	Drug: adapalene gel, 0.3% Drug: tretinoin 0.05% emollient cream

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
Dates of recruitment period: First subject was enrolled on June 17, 2008 and the last subject was enrolled on July 24, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Wash-out period at baseline: 2 wks topical alpha-hydroxy, glycolic, salicylic, lactic, & beta-hydroxy acids, topical vitamin A, ascorbic acid, vitamin E, corticosteroids on face; 4 wks systemic corticosteroids; 3 mos topical retinoids, superficial chemical peels/exfoliation/microdermabrasion; 6 mos botulinum toxin on the face; 1 yr oral retinoids.

Reporting Groups

	Description
Differin® Gel, 0.3%	adapalene gel 0.3% - apply once daily in the evening for 24 weeks
Tretinoin Emollient Cream	Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks

Participant Flow: Overall Study

	Differin® Gel, 0.3%	Tretinoin Emollient Cream
STARTED	15	15
COMPLETED	12	13
NOT COMPLETED	3	2
Adverse Event	0	1
Lost to Follow-up	1	0
Protocol Violation	0	1
Withdrawal by Subject	1	0
Surgery for pre-existing neck pain	1	0

Baseline Characteristics

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Reporting Groups

	Description
Differin® Gel, 0.3%	adapalene gel 0.3% - apply once daily in the evening for 24 weeks
Tretinoin Emollient Cream	Tretinoin Emollient Cream 0.05% - apply topically once daily in the evening for 24 weeks

Baseline Measures

	Differin® Gel, 0.3%	Tretinoin Emollient Cream	Total
Number of Participants [units: participants]	15	15	30
Age [units: years] Mean ± Standard Deviation	60.9 ± 11.37	61.3 ± 9.58	61.1 ± 10.33
Gender [units: participants]
Female	10	12	22
Male	5	3	8

Outcome Measures

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1. Primary:

Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24 [ Time Frame: baseline to week 24 ]

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2. Secondary:

Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24 [ Time Frame: baseline, week 12 and week 24 ]

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3. Secondary:

Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12. [ Time Frame: baseline to week 12 ]

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4. Secondary:

Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24 [ Time Frame: week 12 and week 24 ]

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5. Secondary:

Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24 [ Time Frame: week 12 and week 24 ]

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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: 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.

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: Ronald W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
phone: 817-961-5358
e-mail: ron.gottschalk@galderma.com

No publications provided

Responsible Party:	Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00647556 History of Changes
Other Study ID Numbers:	US10067
Study First Received:	March 26, 2008
Results First Received:	January 28, 2011
Last Updated:	March 16, 2011
Health Authority:	United States: Food and Drug Administration