An interventional study of Placebo Vehicle Cream and Centella Asiatica Cream in Stretch Marks, Striae Distensae and Cosmetic Appearance of Stretch Marks, sponsored by University of California, Davis. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-04.
Sponsored by University of California, Davis · Not applicable, Interventional, and Other
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.
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.
39 studies on the registry are indexed under Striae Distensae; 6 are open to participants now.
This study's enrollment of 15 is below the median of 28 across 38 interventional studies indexed under Striae Distensae.
Browse Striae Distensae studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Lipoderm Cream alone
1% Centella Asiatica in lipoderm
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)
Time frame: 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.
Time frame: 12 weeks
| Milestone | All Study Participants |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
| Milestone | All Study Participants |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
| Milestone | All Study Participants |
|---|---|
| Started | 15 |
| Completed | 13 |
| Not completed | 2 |
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)
| Participants | Placebo Vehicle Cream | Centella Asiatica |
|---|---|---|
| Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks | 3 | 5 |
Stretch mark width: measured at week 12. This will be converted into the percentage of reduction from the baseline.
| percent change | Placebo Vehicle Cream | Centella Asiatica |
|---|---|---|
| Stretch Mark Width/Area | 0.8 ± 0.05 | 0.87 ± 0.06 |
Collected over Adverse event data was collected during the study duration of 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Vehicle Cream | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Centella Asiatica | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
The right and the left side of the abdomen were randomized by binary randomization to treatment with CA cream or the vehicle cream. Therefore each patient will serve as their own control.
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 42.5 (24 to 63) |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 15 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 8 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | All Study Participants |
|---|---|
| United States | 15 |
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University of California, Davis