Study to Assess DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Forearms and Hands (CCCR28-2013)
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. Assessments will be made through ongoing objective measurements and clinical ratings.
To confirm the safety (local tolerance) of DerMend Moisturizing Bruise Formula.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Contralateral, Controlled Study to Assess the Efficacy of DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Mature Skin of the Forearms and Hands|
- Reduction of Bruising [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Investigator Global Assessment (IGA) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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:
- <25% improvement
- 25% to 50% improvement
- 51% to 75% improvement
- >75% improvement
|Study Start Date:||July 2013|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: DerMend Moisturizing Bruise Formula
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.
Drug: DerMend Moisturizing Bruise Formula
DerMend Moisturizing Bruise Formula, a skin care cream containing a proprietary blend of retinol, ceramides, arnica oil, and alpha hydroxy acids and other ingredients.
Other Name: DerMend
Placebo Comparator: Non-active placebo 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.
Twenty subjects with mature skin, at one study center, with bruising and moderate to severe photodamage will be selected for the study. Twenty subjects will be enrolled to achieve a total of 40 arms to be analyzed. At baseline, the Subject will be instructed to use the study cream on one forearm and hand while a control cream will be used on the other. Both the study cream and the control cream will be provided in containers labeled Left and Right so that the subjects are blinded. Each cream labeled Left and Right will be randomized with either the treatment or control cream in the Left container and the opposite cream will be assigned to the Right container. Each subject will always get the control cream in one container and the treatment cream in the other container. Each subject will be randomized to apply cream Right to the right forearm and hand. Subject will apply cream Left to the left forearm and hand. At each visit, the Evaluator will count the total number of bruises, determine the size of each bruise and assess each forearm and hand for surface roughness, laxity and mottled hyperpigmentation. Furthermore, subjective investigator and subject global assessments of bruising, skin roughness, wrinkling and pigmentation will be measured. Subjects will be evaluated at weeks 0 (baseline), 2, 4, 6, 8, 10, and 12. Additionally, standardized, high-resolution digital photographs will be taken at each visit using the Vectra software..
The following scales will be used for grading these features: Roughness (degree of scaling and surface texture) - very smooth (1), mostly smooth (2), slightly rough (3), rough (4), very rough (5). Laxity (ability to spring back after pinching the skin) - very tight (1), somewhat tight (2), somewhat loose (3), loose (4), very loose (5). Mottled hyperpigmentation (a combination of lentigines and hyperpigmented and hypopigmented spots) - very even (1), mostly even with few blotches (2), blotchy (3), mostly blotchy (4), very blotchy (5).
Secondary endpoints will be measured including the speed of healing (measured by the two week average percentage change in bruising) and a reduction in the Investigator's and Subject's Global Assessment compared to baseline after twelve weeks. The following 5-point scale will be used for both the Investigator's and Subject's Global Assessments: 0, no improvement; 1, <25% improvement; 2, 25% to 50% improvement; 3, 51% to 75% improvement; and 4, >75% improvement.
Finally, adverse events, including but not limited to redness, swelling, blistering, ulceration, bleeding, itch or pain, will be monitored at each visit and assessed by both the Subject and the Evaluator.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01910831
|United States, Florida|
|Center for Clinical and Cosmetic Research|
|Aventura, Florida, United States, 33180|
|Principal Investigator:||Mark S Nestor, MD, PhD||Director|
|Study Chair:||Brian Berman, MD, PhD||Co-director|
|Study Chair:||Julie A Santos, PA-C, CRC||Study Coordinator|
|Study Chair:||Andrew C Frisina, MS||Study Coordinator|