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

Twenty subjects with mature skin, at one study center, with bruising and moderate to severe
photodamage will be selected for the study. 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.

Inclusion Criteria:

- Patients who meet all of the following criteria are eligible for this study:

1. Male and female subjects who are 60-80 years of age, with phototypes I to IV.

2. Subjects who have provided written, informed consent.

3. Subjects with multiple bruises on both forearms and hands.

4. Subjects with moderate to severe photodamage on forearms and hands.

5. Subjects with relatively equal photodamage on both forearms and hands.

6. Subjects who are willing to follow the treatment schedule.

7. Subjects who are willing to maintain their usual sunscreen or use of
photoprotective clothing during outdoor activities.

Exclusion Criteria:

- Patients who meet any of the following criteria are not eligible for this study:

1. Participation in a clinical drug or device research study within 30 days of
enrollment or participation in a research study concurrent with this study;

2. Subjects with history of bleeding disorders;

3. Subjects with use of isotretinoin in the past 12 months;

4. Subjects with a pacemaker or internal defibrillator;

5. Subjects who take more than 2 anticoagulant therapies.

6. Treatment of any type of cancer within the last 6 months;

7. Subjects who are unable to communicate or cooperate with the Investigator due to
language problems, poor mental development, or impaired cerebral function;

8. History of hypersensitivity or allergic reactions to any of the study
preparations as described in the Investigator's Brochure, including known
sensitivities to any ingredient;

9. Concomitant use of potentially irritating over-the-counter products that contain
ingredients such as arnica, alpha-hydroxy acid, salicylic acid, retinol or
glycolic acid;

10. Subjects who present with one or more conditions which, in the opinion of the
investigator, making the subject unsuitable for participation.

11. Subjects who apply any topicals other than the study treatment or their usual
sunscreen.