Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

Conditions
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Stretch Marks, Striae Distensae, Cosmetic Appearance of Stretch Marks

Intervention / Treatment
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* Other: Placebo Vehicle Cream
* Other: Centella Asiatica Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 15 patients were enrolled. All 15 patients had one side of abdomen randomized to placebo and one randomized to Centella Asiatica.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Vehicle Cream<br>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. | Other: Placebo Vehicle Cream<br>* Lipoderm Cream alone<br>|
| Experimental: Centella Asiatica Cream<br>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. | Other: Centella Asiatica Cream<br>* 1% Centella Asiatica in lipoderm<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gotu kola, centella asiatica