CICATRIX in the Treatment of Hypertrophic Scars and Keloi... | NCT00993005

Studies
CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

NCT00993005

Sponsor

Catalysis SL

Status

Completed

Last Update Posted

Dec 8, 2010Estimated

Enrollment

90Estimated

Phase

Phase 3

Conditions

Hypertrophic Scars
Keloids

Interventions

Cicatrix
Placebo

Countries

Cuba

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 7, 2009

First Submission Date that Met QC Criteria

Oct 8, 2009

First Posted Date

Oct 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2010

Last Update Posted Date

Dec 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 90.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Cicatrix	Other: Cicatrix
B	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cicatrix	Other	Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of adverse effects at week 12 (end of the treatment)		12 weeks
Photographs of lesions at week 12 (end of the treatment)		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hypertrophic wound or keloid with no treatment for more than 1 month.
Signed informed consent.

Exclusion Criteria:

Usage of steroids within 30 days.
Malignant neoplastic conditions.
Alcoholism.
Handicap and/or psychiatric condition preventing treatment accomplishment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omara Lemus, MD	"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital		Havana	La Habana	10400	Cuba

Condition Browse Module

MeSH Terms

ID	Term
D017439	Cicatrix, Hypertrophic
D007627	Keloid

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003358	Cosmetics

Ancestor Terms

ID	Term
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D006795	Household Products
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided