Trial Outcomes & Findings for Study to Assess DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Forearms and Hands (NCT NCT01910831)

NCT ID: NCT01910831

Last Updated: 2019-12-02

Results Overview

To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in improving the appearance of bruising and reducing the appearance of photoaging of the forearms and hands in mature skin.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

12 weeks

Results posted on

2019-12-02

Participant Flow

The recruitment in this study is defined as follows: 20 individual subjects were recruited to participate in the study. 40 arms (1 left arm and 1 right arm) were analyzed for the results. The N for data analysis is "40".

Participant milestones

Participant milestones
Measure	DerMend Moisturizing Bruise Formula vs. Vehicle Control Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control. DerMend Moisturizing Bruise Formula vs. Vehicle control.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Assess DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Forearms and Hands

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=20 Participants Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Age, Continuous	73.60 years STANDARD_DEVIATION 5.73 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.

Outcome measures

Outcome measures
Measure	LEFT Arm Randomized to DerMend Moisturizing Bruise Formula n=20 Participants Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control. DerMend Moisturizing Bruise Formula	LEFT Arm Randomized to Non-active Placebo Control n=20 Participants Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
Reduction of Bruising	3.74 cm squared Standard Deviation 3.39	4.50 cm squared Standard Deviation 3.22

SECONDARY outcome

Timeframe: 12 Weeks

To determine efficacy with respect to the IGA of improving the appearance of "bruising" and reducing the appearance of photoaging of the forearms and hands: IGA: 0=No improvement 1. \<25% improvement 2. 25% to 50% improvement 3. 51% to 75% improvement 4. \>75% improvement

Outcome measures

Outcome measures
Measure	LEFT Arm Randomized to DerMend Moisturizing Bruise Formula n=20 Participants Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control. DerMend Moisturizing Bruise Formula	LEFT Arm Randomized to Non-active Placebo Control n=20 Participants Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
Investigator Global Assessment (IGA)	1.60 units on a scale Standard Deviation 1.23	2.05 units on a scale Standard Deviation 1.19

Adverse Events

All Participants

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

Andrew Frisina, Clinical Research Coordinator

Center for Clinical and Cosmetic Research

Phone: 305 933 6716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place