CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Keloids; Hypertrophic Scars

Treatments: Other: Cicatrix; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00993005

CAT-0910-CU

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Cicatrix

Treatment:

Other: Cicatrix

B

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo