A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

This study has been completed.

Study NCT00587587 Information provided by Organogenesis

First Received on December 21, 2007. Last Updated on August 16, 2011 History of Changes

Results First Received: June 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Keloid
Interventions:	Device: Apligraf Other: Standard dressing regimen

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
Apligraf	Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
Control	Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary

Participant Flow: Overall Study

	Apligraf	Control
STARTED	17	13
COMPLETED	11	12
NOT COMPLETED	6	1
Lost to Follow-up	6	1

Baseline Characteristics

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Reporting Groups

	Description
Apligraf	Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
Control	Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary

Baseline Measures

	Apligraf	Control	Total
Number of Participants [units: participants]	17	13	30
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	17	13	30
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	32.7 ± 12.9	36.7 ± 13.5	34.4 ± 13.1
Gender [units: participants]
Female	11	10	21
Male	6	3	9
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	1	1	2
Not Hispanic or Latino	16	12	28
Unknown or Not Reported	0	0	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	16	12	28
White	1	1	2
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Outcome Measures

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1. Primary:

The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented. [ Time Frame: 52 weeks ]

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2. Secondary:

Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS) [ Time Frame: Baseline to Week 52 or Last Visit ]

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3. Secondary:

Cumulative Incidence of Keloid Recurrence at Week 52 [ Time Frame: 52 weeks ]

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4. Secondary:

Degree of Recurrence (Scar Firmness) [ Time Frame: Week 52 or Last Visit ]

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5. Secondary:

Degree of Recurrence (Scar Thickness) [ Time Frame: Week 52 or Last visit ]

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6. Secondary:

Physician Global Assessment [ Time Frame: Week 52 or Last Visit ]

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7. Secondary:

Subject Global Assessment [ Time Frame: Week 52 or Last Visit ]

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8. Secondary:

Decreased Utilization of Intralesional Steroid Intervention [ Time Frame: 52 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.

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: Director of Clinical Operations
Organization: Organogenesis Inc.
phone: 781-575-0775
e-mail: clinical@organo.com

No publications provided

Responsible Party:	Katherine B. Giovino, Director of Clinical Operations, Organogenesis Inc.
ClinicalTrials.gov Identifier:	NCT00587587 History of Changes
Other Study ID Numbers:	06-KEL-001-AG
Study First Received:	December 21, 2007
Results First Received:	June 7, 2011
Last Updated:	August 16, 2011
Health Authority:	United States: Food and Drug Administration