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Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

Primary Purpose

Stretch Marks, Striae Distensae, Cosmetic Appearance of Stretch Marks

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo Vehicle Cream
Centella Asiatica Cream
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stretch Marks focused on measuring gotu kola, centella asiatica

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • University of California Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Vehicle Cream

Centella Asiatica Cream

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 6, 2015
Last Updated
May 2, 2021
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02601105
Brief Title
Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks
Official Title
Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stretch Marks, Striae Distensae, Cosmetic Appearance of Stretch Marks
Keywords
gotu kola, centella asiatica

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
15 patients were enrolled. All 15 patients had one side of abdomen randomized to placebo and one randomized to Centella Asiatica.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Centella Asiatica Cream
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Vehicle Cream
Intervention Description
Lipoderm Cream alone
Intervention Type
Other
Intervention Name(s)
Centella Asiatica Cream
Intervention Description
1% Centella Asiatica in lipoderm
Primary Outcome Measure Information:
Title
Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks
Description
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)
Time Frame
12 weeks
Title
Stretch Mark Width/Area
Description
Stretch mark width: measured at week 12. This will be converted into the percentage of reduction from the baseline.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja K Sivamani, MD, MS, CAT
Organizational Affiliation
UC Davis Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16987267
Citation
Cho S, Park ES, Lee DH, Li K, Chung JH. Clinical features and risk factors for striae distensae in Korean adolescents. J Eur Acad Dermatol Venereol. 2006 Oct;20(9):1108-13. doi: 10.1111/j.1468-3083.2006.01747.x.
Results Reference
background
PubMed Identifier
11081995
Citation
Brinkhaus B, Lindner M, Schuppan D, Hahn EG. Chemical, pharmacological and clinical profile of the East Asian medical plant Centella asiatica. Phytomedicine. 2000 Oct;7(5):427-48. doi: 10.1016/s0944-7113(00)80065-3.
Results Reference
background
PubMed Identifier
11666128
Citation
Incandela L, Cesarone MR, Cacchio M, De Sanctis MT, Santavenere C, D'Auro MG, Bucci M, Belcaro G. Total triterpenic fraction of Centella asiatica in chronic venous insufficiency and in high-perfusion microangiopathy. Angiology. 2001 Oct;52 Suppl 2:S9-13.
Results Reference
background
PubMed Identifier
15533060
Citation
Lu L, Ying K, Wei S, Fang Y, Liu Y, Lin H, Ma L, Mao Y. Asiaticoside induction for cell-cycle progression, proliferation and collagen synthesis in human dermal fibroblasts. Int J Dermatol. 2004 Nov;43(11):801-7. doi: 10.1111/j.1365-4632.2004.02047.x.
Results Reference
background
PubMed Identifier
6027541
Citation
Rosen H, Blumenthal A, McCallum J. Effect of asiaticoside on wound healing in the rat. Proc Soc Exp Biol Med. 1967 May;125(1):279-80. doi: 10.3181/00379727-125-32070. No abstract available.
Results Reference
background
PubMed Identifier
9731470
Citation
Sunilkumar, Parameshwaraiah S, Shivakumar HG. Evaluation of topical formulations of aqueous extract of Centella asiatica on open wounds in rats. Indian J Exp Biol. 1998 Jun;36(6):569-72.
Results Reference
background
PubMed Identifier
25201840
Citation
Gungor S, Sayilgan T, Gokdemir G, Ozcan D. Evaluation of an ablative and non-ablative laser procedure in the treatment of striae distensae. Indian J Dermatol Venereol Leprol. 2014 Sep-Oct;80(5):409-12. doi: 10.4103/0378-6323.140296.
Results Reference
result
PubMed Identifier
22374035
Citation
Mazzarello V, Farace F, Ena P, Fenu G, Mulas P, Piu L, Rubino C. A superficial texture analysis of 70% glycolic acid topical therapy and striae distensae. Plast Reconstr Surg. 2012 Mar;129(3):589e-590e. doi: 10.1097/PRS.0b013e3182419c40. No abstract available.
Results Reference
result
PubMed Identifier
23237514
Citation
Garcia Hernandez JA, Madera Gonzalez D, Padilla Castillo M, Figueras Falcon T. Use of a specific anti-stretch mark cream for preventing or reducing the severity of striae gravidarum. Randomized, double-blind, controlled trial. Int J Cosmet Sci. 2013 Jun;35(3):233-7. doi: 10.1111/ics.12029. Epub 2013 Jan 15.
Results Reference
result

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Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

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