Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

NCT02601105 | Completed Results

• 1 other identifier: 637397
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stretch Marks; Striae Distensae; Cosmetic Appearance of Stretch Marks

Keywords

gotu kola; centella asiatica

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Placebo Vehicle Cream

PLACEBO COMPARATOR

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

Centella Asiatica Cream

EXPERIMENTAL

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

Interventions

Placebo Vehicle Cream OTHER

Lipoderm Cream alone

Placebo Vehicle Cream

Centella Asiatica Cream OTHER

1% Centella Asiatica in lipoderm

Centella Asiatica Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking subjects over the age of 18
• Subjects clinically diagnosed with stretch marks

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95816, United States

Location

Related Publications (9)

• 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.

  PMID: 16987267 BACKGROUND

• 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.

  PMID: 11081995 BACKGROUND

• 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.

  PMID: 11666128 BACKGROUND

• 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.

  PMID: 15533060 BACKGROUND

• 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.

  PMID: 6027541 BACKGROUND

• 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.

  PMID: 9731470 BACKGROUND

• 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.

  PMID: 25201840 RESULT

• 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.

  PMID: 22374035 RESULT

• 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.

  PMID: 23237514 RESULT

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Raja Sivamani MD
• Organization: UC Davis Department of Dermatology

dermstudies@ucdavis.edu

916-703-5145

Study Officials

• Raja K Sivamani, MD, MS, CAT

  UC Davis Department of Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 15 patients were enrolled. All 15 patients had one side of abdomen randomized to placebo and one randomized to Centella Asiatica.

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 10, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-05

Locations

US (1)