Hypertrophic Scars, Keloids
Conditions
Keywords
Hypertrophic scars, Keloids, Asian Gotu Kola, Asian Pennywort
Brief 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.
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 scar rubbing in different directions for 2 minutes, three times a day, for 12 weeks.
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 scar rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse effects at week 12 (end of the treatment) | 12 weeks |
| Photographs of lesions at week 12 (end of the treatment) | 12 weeks |
Countries
Cuba
Outcome results
None listed