Skip to main content
OpenTrials
Completed

NCT Number: NCT02601105

Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

The purpose of this study is to clinically evaluate the efficacy, safety as well as patient satisfaction in the use of topical Centella asiatica (CA) on the cosmetic appearance of stretch marks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stretch Marks Cosmetic Appearance of Stretch Marks Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Striae Distensae

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis

Sacramento, California, 95816, United States

About this study

Subjects with abdominal stretch marks will be enrolled in to this study. The presence of abdominal stretch marks will be confirmed by a board certified dermatologist. The right and the left side of the abdomen will be randomized by binary randomization to treatment with CA cream or the vehicle cream. Therefore each patient will serve as their own control.

Each half of the abdomen will be subjected to topical treatment with CA 1% Cream formulated in PCCA Lipoderm® base or PCCA Lipoderm® base as the placebo vehicle treatment based on prior randomization. The creams will be given to the patient in blinded fashion: Cream A (containing CA) and cream B (vehicle/placebo) with instructions apply both formulations daily at night.

Patients will be asked to return to clinic at 6 weeks and 12 weeks for follow up assessment for a total of 3 sessions (baseline, 6 weeks, 12 weeks). High-resolution digital photographs of the stretch marks will be taken at baseline and at each follow-up visit to document clinical response. Two physician graders blinded to the photographs and the treatments will assess cosmetic outcome on a six-point analog scale

The width of the treated stretch marks in each subject will also be measured at the baseline and 8 weeks after the final treatment. The difference of the width will be converted into the percentage of reduction from the baseline.

Subjects will also be asked to complete two surveys at each visit. The two surveys include patient satisfaction with cosmetic and clinical outcome based on a five-point scale.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking subjects over the age of 18
  • Subjects clinically diagnosed with stretch marks

Exclusion criteria

  • History of keloid scarring
  • Isotretinoin use within the last 6 months
  • Oral prednisone use within the last 3 months
  • Non-ablative laser procedures to the abdomen within 1 year of study initiation
  • Ablative resurfacing procedures to the abdomen within 3 years of the study initiation
  • Pregnancy
  • Use of immunosuppressive drugs
  • Known hypersensitivity to Centella asiatica

Treatment and study plan

Placebo Vehicle Cream

Other

Lipoderm Cream alone

Centella Asiatica Cream

Other

1% Centella Asiatica in lipoderm

Primary outcomes

  1. Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks

    Time frame: 12 weeks

    Assessed by four blinded evaluators by observing comparative baseline photographs using 6 point scale (worsened = -1 points, no improvement = 0 points, mild = 1 points, <25% improvement, moderate = 2 points, 26-50% improvement, good = 3 points, 51-75% improvement, excellent = 4 points, >75% improvement)

  2. Stretch Mark Width/Area

    Time frame: 12 weeks

    Stretch mark width: measured at week 12. This will be converted into the percentage of reduction from the baseline.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2015
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.