Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02601105
Other study ID # 637397
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date November 2015

Study information

Verified date May 2021
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Placebo Vehicle Cream
Lipoderm Cream alone
Centella Asiatica Cream
1% Centella Asiatica in lipoderm

Locations

Country Name City State
United States University of California Davis Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (9)

See more »

Outcome

Type Measure Description Time frame Safety issue
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) 12 weeks
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT06000839 - A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology) N/A
Completed NCT05461755 - Treatment of Striae Distensae With Fractional Radiofrequency and Topical Tretinoin Phase 2
Terminated NCT02452359 - Clinical Evaluation of Using Intense Pulsed Light for Improving the Appearance of Striae Distensae N/A
Recruiting NCT05827913 - Efficacy and Safety of Polylevolactic Acid Injection Combined With 1565nm Non-ablative Fractional Laser in the Treatment of Striae Distensae N/A
Completed NCT02126566 - Multiclear Treatment for Striae Distensae - A Pilot Study Phase 2
Completed NCT03858543 - Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae Early Phase 1
Completed NCT03390439 - Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser N/A
Recruiting NCT04092881 - Efficacy of Short Pulsed 1064 nm Nd-YAG Laser Versus 10600 nm Fractional CO2 Laser in Treatment of Striae Alba N/A
Completed NCT02510768 - A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba Phase 1