Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks
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.
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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Conditions
Stretch Marks
Intervention
Centella Asiatica, Placebo Vehicle Cream
Status
Completed
Source
University of California, Davis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT02601105
- ClinicalTrials.gov processed this data on November 10, 2015
Published on BioPortfolio: 2015-11-11T18:53:39-0500
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Medical and Biotech [MESH] Definitions
Centella
A plant of the family APIACEAE which is the source of asiatic acid and asiaticoside. Centella asiatica (L.) Urb. = Hydrocotyle asiatica L. is known for effect on peripheral circulation.
Pulmonary Stretch Receptors
Stretch receptors found in the bronchi and bronchioles. Pulmonary stretch receptors are sensors for a reflex which stops inspiration. In humans, the reflex is protective and is probably not activated during normal respiration.
Ice Cream
A frozen dairy food made from cream or butterfat, milk, sugar, and flavorings. Frozen custard and French-type ice creams also contain eggs.
Printers' Marks
Symbols or text that identifies a book as the work of a specific printer.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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