Clinical trial NCT02601105: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stretch Marks
Striae Distensae
Cosmetic Appearance of Stretch Marks
Keywords: gotu kola
centella asiatica
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 15 patients were enrolled. All 15 patients had one side of abdomen randomized to placebo and one randomized to Centella Asiatica.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks
timeFrame: 12 weeks
measure: Stretch Mark Width/Area
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: UC Davis Department of Dermatology
name: Raja K Sivamani, MD, MS, CAT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.