Skip to main content
OpenTrials
Completed

NCT Number: NCT00993005

CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertrophic Scars Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Fibrosis Keloid Keloids Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Cosmetic

Placebo

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

Primary outcomes

  1. Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)

    Time frame: 12 weeks

Secondary outcomes

  1. Occurrence of adverse effects at week 12 (end of the treatment)

    Time frame: 12 weeks

  2. Photographs of lesions at week 12 (end of the treatment)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 9, 2009
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.