Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

Not Applicable

Completed

• Conditions: Stretch Marks; Striae Distensae; Cosmetic Appearance of Stretch Marks
• Interventions: Other: Centella Asiatica Cream; Other: Placebo Vehicle Cream

• Registration Number: NCT02601105
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-07
• Study First Posted: 2015-11-10
• Results First Submitted: 2017-03-30
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-02
• Last Update Submitted: 2021-05-02
• Results First Posted: 2021-05-04
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1. English-speaking subjects over the age of 18
2. Subjects clinically diagnosed with stretch marks

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Centella Asiatica Cream	Centella Asiatica Cream	An alcoholic extract of CA (verified by HPLC) mixed into a Lipoderm® base served as the treatment cream to be applied every night to demarcated 10 x 10 cm area containing stretch marks on the opposite side of the abdomen for 12 weeks.
Placebo Vehicle Cream	Placebo Vehicle Cream	Lipoderm® base served as the placebo vehicle control to be applied every night to demarcated 10 x 10 cm area containing stretch marks on randomly assigned side of abdomen for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks	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)
Stretch Mark Width/Area	12 weeks	Stretch mark width: measured at week 12. This will be converted into the percentage of reduction from the baseline.

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States