Study to Assess DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Forearms and Hands
Condition: Purpura
MeSH terms: Purpura
Intervention: DerMend Moisturizing Bruise Formula; Non-active placebo control
Intervention description: DerMend Moisturizing Bruise Formula, a skin care cream containing a proprietary blend of retinol, ceramides, arnica oil, and alpha hydroxy acids and other ingredients.; Non-active placebo control
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: bruising, reduction, older age, aging

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.
    

Eligibility 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.