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Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

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ClinicalTrials.gov Identifier: NCT02601105
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Raja Sivamani, MD, University of California, Davis

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 Drug: Centella Asiatica Drug: Placebo Vehicle Cream Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks
Study Start Date : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

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.
Drug: Placebo Vehicle Cream
Lipoderm cream
Other Name: Vehicle control

Active Comparator: Centella Asiatica
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.
Drug: Centella Asiatica
1% Centella Asiatica in lipoderm
Other Name: Gotu Kola




Primary Outcome Measures :
  1. Cosmetic Outcome assessed on a six-point analog scale [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Compared against baseline by planimetry after stretch mark tracing


Secondary Outcome Measures :
  1. Patient Satisfaction Rating on 5-point scale [ Time Frame: 6 weeks ]
    Rated by each subject using five-point scale (0=not satisfied, 1=slightly satisfied, 2=satisfied, 3=very satisfied, 4=extremely satisfied) and a rating of their experience with skin sensitivity and pain on four point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).

  2. Patient Satisfaction Rating on 5-point scale [ Time Frame: 12 weeks ]
    Rated by each subject using five-point scale (0=not satisfied, 1=slightly satisfied, 2=satisfied, 3=very satisfied, 4=extremely satisfied) and a rating of their experience with skin sensitivity and pain on four point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe)

  3. Cosmetic Outcome assessed on a six-point analog scale [ Time Frame: 6 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)

  4. Stretch Mark Width/Area [ Time Frame: 6 weeks ]
    Compared against baseline by planimetry after stretch mark tracing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601105


Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Raja K Sivamani, MD, MS, CAT UC Davis Department of Dermatology

Publications of Results:
Other Publications:
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Responsible Party: Raja Sivamani, MD, Assistant Professor of Clinical Dermatology, University of California, Davis
ClinicalTrials.gov Identifier: NCT02601105     History of Changes
Other Study ID Numbers: 637397
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Raja Sivamani, MD, University of California, Davis:
gotu kola
centella asiatica

Additional relevant MeSH terms:
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Striae Distensae
Skin Manifestations
Signs and Symptoms