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CompletedNCT00991367Updated Dec 8, 2010

CICATRIX in the Treatment of Recent Post-surgical Scars

A Phase 3 interventional study of Cicatrix and Placebo in Post-surgical Scars, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2010-12-08.

Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Post-surgical Scars

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Keywords

  • Post-surgical scars
  • Asian Gotu Kola
  • Asian Pennywort
03

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

This study's planned enrollment of 90 is above the median of 39 across 251 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Catalysis SL is the lead sponsor of 52 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    A

    Cicatrix

    Other: Cicatrix

  • Placebo comparator
    B

    Placebo

    Other: Placebo

Interventions

  • OtherCicatrix

    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

  • OtherPlacebo

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

  2. Photographs of lesions at week 4 (end of the treatment)

    Time frame: 4 weeks

07

Study locations

1 site
  • "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
    Havana City, Havana 10400, Cuba
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00991367
Lead sponsor
Catalysis SL
First posted
Oct 8, 2009
Start date
Oct 2009
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Dec 8, 2010

Study contacts

Omara Lemus, MD
principal investigator · "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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