Study to Assess DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Forearms and Hands
Condition: Purpura
MeSH terms: Purpura
Study type: Interventional
Phase: Phase 4

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 description: 
      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.
    

Intervention name(s): DerMend Moisturizing Bruise Formula; Non-active placebo control
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): DerMend
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bruising, reduction, older age, aging