Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT02601105
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stretch Marks; Striae Distensae; Cosmetic Appearance of Stretch Marks	Other: Placebo Vehicle Cream; Other: Centella Asiatica Cream	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: 15 patients were enrolled. All 15 patients had one side of abdomen randomized to placebo and one randomized to Centella Asiatica.15 patients were enrolled. All 15 patients had one side of abdomen randomized to placebo and one randomized to Centella Asiatica.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Other: Placebo Vehicle Cream; Lipoderm Cream alone
Experimental: 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.	Other: Centella Asiatica Cream; 1% Centella Asiatica in lipoderm

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis	Sacramento	California	United States	95816

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Raja K Sivamani, MD, MS, CAT, UC Davis Department of Dermatology

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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.
• 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. Review.
• 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.
• 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.
• 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.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT02601105
• Other Study ID Numbers: 637397
• First Posted: Nov 10, 2015
• Last Update Posted: May 4, 2021
• Last Verified: May 1, 2021

• Keywords provided by University of California, Davis: gotu kola; centella asiatica
• Additional relevant MeSH terms: Striae Distensae

Study Results

Participant Flow

Pre-assignment Detail	The right and the left side of the abdomen were randomized by binary randomization to treatment with CA cream or the vehicle cream. Therefore each patient will serve as their own control.

Arm/Group Title	All Study Participants
Arm/Group Description	Placebo Vehicle Cream: Lipoderm Cream Alone 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. Centella Asiatica: 1% Centella Asiatica in Lipoderm 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.
Period Title: Placebo Cream; Centella Asiatica Bsln.
STARTED	15
COMPLETED	15
NOT COMPLETED	0
Period Title: Placebo Cream; Centella Asiatica Bsln.
STARTED	15
COMPLETED	15
NOT COMPLETED	0
Period Title: Placebo Cream; Centella Asiatica Bsln.
STARTED	15
COMPLETED	13
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Placebo Vehicle Cream: Lipoderm Cream Alone 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. Centella Asiatica: 1% Centella Asiatica in Lipoderm 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.
Overall Participants	15
Overall Side of Abdomen	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42.5
Sex: Female, Male (Count of Participants)
Female	15 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 13.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 20%
White	8 53.3%
More than one race	1 6.7%
Unknown or Not Reported	1 6.7%
Region of Enrollment (Count of Participants)
United States	15 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

13 participants completed all study procedures and were included in data analysis.

Arm/Group Title	Placebo Vehicle Cream	Centella Asiatica
Arm/Group 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. Placebo Vehicle Cream: Lipoderm 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. Centella Asiatica: 1% Centella Asiatica in lipoderm
Measure Participants	13	13
Count of Participants [Participants]	3 20%	5 16.7%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

13 participants completed all study procedures and were included in data analysis.

Arm/Group Title	Placebo Vehicle Cream	Centella Asiatica
Arm/Group 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. Placebo Vehicle Cream: Lipoderm 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. Centella Asiatica: 1% Centella Asiatica in lipoderm
Measure Participants	13	13
Mean (Standard Error) [percent change]	0.8 (0.05)	0.87 (0.06)

Adverse Events

Time Frame	Adverse event data was collected during the study duration of 12 weeks.
Arm/Group Title	Placebo Vehicle Cream		Centella Asiatica
Arm/Group 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. Placebo Vehicle Cream: Lipoderm 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. Centella Asiatica: 1% Centella Asiatica in lipoderm
All Cause Mortality
	Placebo Vehicle Cream		Centella Asiatica
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Placebo Vehicle Cream		Centella Asiatica
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Vehicle Cream		Centella Asiatica
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.