CICATRIX in the Treatment of Recent Post-surgical Scars

NCT ID: NCT00991367

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of recent post-surgical scars. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to be recruited and randomized for the study is 90.

Detailed Description

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Conditions

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Post-surgical Scars

Keywords

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Post-surgical scars Asian Gotu Kola Asian Pennywort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Cicatrix

Group Type EXPERIMENTAL

Cicatrix

Intervention Type 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 lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.

Interventions

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Cicatrix

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 lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.

Intervention Type OTHER

Placebo

Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.

Intervention Type OTHER

Other Intervention Names

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Cosmetic

Eligibility Criteria

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Inclusion Criteria

* Recent (less than 48 hours) post-surgical wound

Exclusion Criteria

* Post-surgical wound with sepsis
* Usage of steroids within 30 days
* Malignant neoplastic conditions
* Alcoholism
* Handicap and/or psychiatric condition preventing treatment accomplishment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalysis SL

INDUSTRY

Sponsor Role lead

Responsible Party

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"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Principal Investigators

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Omara Lemus, MD

Role: PRINCIPAL_INVESTIGATOR

"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Locations

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"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Havana, La Habana, Cuba

Site Status

Countries

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Cuba

Other Identifiers

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CAT-0909-CU

Identifier Type: -

Identifier Source: org_study_id