NCT00991367

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

1.2 years

First QC Date

October 7, 2009

Last Update Submit

December 7, 2010

Conditions

Post-surgical Scars

Keywords

Post-surgical scarsAsian Gotu KolaAsian Pennywort

Outcome Measures

Primary Outcomes (1)

  • Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)

    4 weeks

Secondary Outcomes (2)

  • Occurrence of adverse effects at week 4 (end of the treatment)

    4 weeks

  • Photographs of lesions at week 4 (end of the treatment)

    4 weeks

Study Arms (2)

A

EXPERIMENTAL

Cicatrix

Other: Cicatrix

B

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CicatrixOTHER

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.

Also known as: Cosmetic
A
PlaceboOTHER

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.

B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Havana, La Habana, 10400, Cuba

Location

MeSH Terms

Interventions

Cosmetics

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesHousehold ProductsTechnology, Industry, and Agriculture

Study Officials

  • Omara Lemus, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

CU(1)