Trial Outcomes & Findings for Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks (NCT NCT02601105)

Last Updated: 2021-05-04

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-05-04

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Placebo Cream; Centella Asiatica Bsln. STARTED	15
Placebo Cream; Centella Asiatica Bsln. COMPLETED	15
Placebo Cream; Centella Asiatica Bsln. NOT COMPLETED	0
Placebo Cream; Centella Asiatica Week 6 STARTED	15
Placebo Cream; Centella Asiatica Week 6 COMPLETED	15
Placebo Cream; Centella Asiatica Week 6 NOT COMPLETED	0
Placebo Cream; Centella Asiatica Week 12 STARTED	15
Placebo Cream; Centella Asiatica Week 12 COMPLETED	13
Placebo Cream; Centella Asiatica Week 12 NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Centella Asiatica and the Cosmetic Appearance of Stretch Marks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=30 Side of Abdomen 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.5 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 13 participants completed all study procedures and were included in data analysis.

Outcome measures

Outcome measures
Measure	Placebo Vehicle Cream n=13 Participants 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. Placebo Vehicle Cream: Lipoderm cream	Centella Asiatica n=13 Participants 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. Centella Asiatica: 1% Centella Asiatica in lipoderm
Cosmetic Outcome- Fraction Improving by at Least 1 Point Increase in Overall Appearance of Stretch Marks	3 Participants	5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 13 participants completed all study procedures and were included in data analysis.

Stretch mark width: measured at week 12. This will be converted into the percentage of reduction from the baseline.

Outcome measures

Outcome measures
Measure	Placebo Vehicle Cream n=13 Participants 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. Placebo Vehicle Cream: Lipoderm cream	Centella Asiatica n=13 Participants 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. Centella Asiatica: 1% Centella Asiatica in lipoderm
Stretch Mark Width/Area	0.8 percent change Standard Error 0.05	0.87 percent change Standard Error 0.06

Adverse Events

Placebo Vehicle Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Centella Asiatica

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raja Sivamani MD

UC Davis Department of Dermatology

Phone: 916-703-5145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place