Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

Striae Distensae Clinical Trial

Official title:

Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601105
• Other study ID #: 637397
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: May 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cosmetic Appearance of Stretch Marks
• Stretch Marks
• Striae Distensae

Intervention

Other:
• Placebo Vehicle Cream
Lipoderm Cream alone
• Centella Asiatica Cream
1% Centella Asiatica in lipoderm

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View Citation

García Hernández JÁ, Madera González D, Padilla Castillo M, Figueras Falcón 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;3 — View Citation

Güngör S, Sayilgan T, Gökdemir 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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