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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-Blind, Contralateral, Controlled Study to Assess the Efficacy of DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Mat

Brief Summary:

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.

Detailed Summary:

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 eve
Sponsor: The Center for Clinical and Cosmetic Research

Current Primary Outcome: Reduction of Bruising [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Investigator Global Assessment (IGA) [ Time Frame: 12 Weeks ]

Original Secondary Outcome: Bruising Reduction Subject [ Time Frame: 12 Weeks ]

Information By: The Center for Clinical and Cosmetic Research

Dates:
Date Received: July 25, 2013
Date Started: July 2013
Date Completion:
Last Updated: March 30, 2015
Last Verified: March 2015