CICATRIX in the Treatment of Recent Post-surgical Scars

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Post-surgical Scars

Treatments: Other: Placebo; Other: Cicatrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00991367

CAT-0909-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 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

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