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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Center for Clinical and Cosmetic Research
• Collaborator: Ferndale Laboratories, Inc.

Criteria

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.