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

NCT01910831 | Completed Phase 4 Results

• 1 other identifier: CCCR 28-2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Purpura

Keywords

bruising, reduction, older age, aging

Outcome Measures

Primary Outcomes (1)

• Reduction of Bruising

  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.

  12 weeks

Secondary Outcomes (1)

• Investigator Global Assessment (IGA)

  12 Weeks

Study Arms (2)

DerMend Moisturizing Bruise Formula

EXPERIMENTAL

Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.

Drug: DerMend Moisturizing Bruise Formula

Non-active placebo control

PLACEBO COMPARATOR

Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.

Drug: Non-active placebo control

Interventions

DerMend Moisturizing Bruise Formula DRUG

DerMend Moisturizing Bruise Formula, a skin care cream containing a proprietary blend of retinol, ceramides, arnica oil, and alpha hydroxy acids and other ingredients.

Also known as: DerMend

DerMend Moisturizing Bruise Formula

Non-active placebo control DRUG

Non-active placebo control

Non-active placebo control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following criteria are eligible for this study:
• Male and female subjects who are 60-80 years of age, with phototypes I to IV.
• Subjects who have provided written, informed consent.
• Subjects with multiple bruises on both forearms and hands.
• Subjects with moderate to severe photodamage on forearms and hands.
• Subjects with relatively equal photodamage on both forearms and hands.
• Subjects who are willing to follow the treatment schedule.
• Subjects who are willing to maintain their usual sunscreen or use of photoprotective clothing during outdoor activities.

You may not qualify if:

• Patients who meet any of the following criteria are not eligible for this study:
• Participation in a clinical drug or device research study within 30 days of enrollment or participation in a research study concurrent with this study;
• Subjects with history of bleeding disorders;
• Subjects with use of isotretinoin in the past 12 months;
• Subjects with a pacemaker or internal defibrillator;
• Subjects who take more than 2 anticoagulant therapies.
• Treatment of any type of cancer within the last 6 months;
• Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function;
• 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;
• Concomitant use of potentially irritating over-the-counter products that contain ingredients such as arnica, alpha-hydroxy acid, salicylic acid, retinol or glycolic acid;
• Subjects who present with one or more conditions which, in the opinion of the investigator, making the subject unsuitable for participation.
• Subjects who apply any topicals other than the study treatment or their usual sunscreen.

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• Ferndale Laboratories, Inc.: collaborator

Study Sites (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Links

• DerMend
• Ferndale Pharma Group

MeSH Terms

Conditions

Purpura; Contusions

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Wounds, Nonpenetrating; Wounds and Injuries

Results Point of Contact

• Title: Andrew Frisina, Clinical Research Coordinator
• Organization: Center for Clinical and Cosmetic Research

A.Frisina@admcorp.com

305 933 6716

Study Officials

• Mark S Nestor, MD, PhD

  Director

  PRINCIPAL INVESTIGATOR

• Brian Berman, MD, PhD

  Co-director

  STUDY CHAIR

• Julie A Santos, PA-C, CRC

  Study Coordinator

  STUDY CHAIR

• Andrew C Frisina, MS

  Study Coordinator

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: July 30, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 2, 2019
• Results First Posted: April 16, 2015

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)