Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

University of California (UC) Davis

Status: Completed

Conditions: Stretch Marks; Cosmetic Appearance of Stretch Marks; Striae Distensae

Treatments: Other: Centella Asiatica Cream; Other: Placebo Vehicle Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02601105

637397

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

---

15 participants in 2 patient groups, including a placebo group

Placebo Vehicle Cream

Placebo Comparator 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.

Treatment:

Other: Placebo Vehicle Cream

Centella Asiatica Cream

Experimental group

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.

Treatment:

Other: Centella Asiatica Cream