CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

Hypertrophic Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993005
• Other study ID #: CAT-0910-CU
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2009
• Last updated: December 7, 2010
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scars
• Hypertrophy
• Keloid
• Keloids

Intervention

Other:
• 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 scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.
• 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 scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.

Locations

Country	Name	City	State
Cuba	"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)		12 weeks	No
Secondary	Occurrence of adverse effects at week 12 (end of the treatment)		12 weeks	Yes
Secondary	Photographs of lesions at week 12 (end of the treatment)		12 weeks	No