Cosmetic Appearance of Stretch Marks, Stretch Marks, Striae Distensae
Conditions
Keywords
gotu kola, centella asiatica
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.
Interventions
Lipoderm Cream alone
OTHERCentella Asiatica Cream
1% Centella Asiatica in lipoderm
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
15 patients were enrolled. All 15 patients had one side of abdomen randomized to placebo and one randomized to Centella Asiatica.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks | 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) |
| Stretch Mark Width/Area | 12 weeks | Stretch mark width: measured at week 12. This will be converted into the percentage of reduction from the baseline. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Placebo Vehicle Cream: Lipoderm Cream Alone
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.
Centella Asiatica: 1% Centella Asiatica in Lipoderm 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. | 15 |
| All Study Participants Placebo Vehicle Cream: Lipoderm Cream Alone
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.
Centella Asiatica: 1% Centella Asiatica in Lipoderm 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. | 30 |
| Total | 45 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 42.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
Population: 13 participants completed all study procedures and were included in data analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Vehicle Cream | Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks | 3 Participants |
| Centella Asiatica | Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks | 5 Participants |
Primary
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
Population: 13 participants completed all study procedures and were included in data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Vehicle Cream | Stretch Mark Width/Area | 0.8 percent change | Standard Error 0.05 |
| Centella Asiatica | Stretch Mark Width/Area | 0.87 percent change | Standard Error 0.06 |