PurpuraPhase 4CCCR-28-2013NCT01910831
Study to Assess DerMend Moisturizing Bruise Formula in Improving the Appearance of Chronically Aged Forearms and Hands
A Phase 4 study testing DerMend Moisturizing Bruise Formula in people with Purpura, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Purpura
- What is being tested?
- DerMend Moisturizing Bruise Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Purpura
- Being tested
- DerMend Moisturizing Bruise Formula, Non-active placebo control
- Keywords
- bruising, reduction, older age, aging
- Medical subject headings
- Purpura, Contusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DerMend Moisturizing Bruise FormulaDrug
Also called DerMend
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 controlDrug
Non-active placebo control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Non-active placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Investigator Global Assessment (IGA)
To determine efficacy with respect to the IGA of improving the appearance of "bruising" and reducing the appearance of photoaging of the forearms and hands:
IGA:
0=No improvement
- <25% improvement
- 25% to 50% improvement
- 51% to 75% improvement
- >75% improvement
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical and Cosmetic Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ferndale Laboratories, Inc.
- Responsible party
- Principal investigator, Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research
- Investigators
- Mark S Nestor, MD, PhD, Principal investigator, DirectorBrian Berman, MD, PhD, Study chair, Co-directorJulie A Santos, PA-C, CRC, Study chair, Study CoordinatorAndrew C Frisina, MS, Study chair, Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910831
- Sponsor's protocol ID
- CCCR 28-2013
- Acronym
- CCCR-28-2013
- Status last verified
- Nov 2019
- First submitted
- 25 Jul 2013
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01910831
- Acronym / sponsor ID
- CCCR-28-2013 / CCCR 28-2013
- Conditions
- Purpura
- Keywords
- bruising, reduction, older age, aging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Center for Clinical and Cosmetic ResearchUniversity, hospital or other
- Collaborators
- Ferndale Laboratories, Inc.
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Posted 16 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DerMend Moisturizing Bruise Formula | Experimental | Drug: DerMend Moisturizing Bruise FormulaApply 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. |
| Non-active placebo control | Placebo comparator | Drug: Non-active placebo controlApply 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DerMend Moisturizing Bruise FormulaAlso: DerMendDerMend Moisturizing Bruise Formula, a skin care cream containing a proprietary blend of retinol, ceramides, arnica oil, and alpha hydroxy acids and other ingredients. | Drug | DerMend Moisturizing Bruise Formula |
| Non-active placebo controlNon-active placebo control | Drug | Non-active placebo control |
Primary outcome
Reduction of Bruising
Time frame: 12 weeks
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.
1 secondary outcome
Investigator Global Assessment (IGA)
Time frame: 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- DerMendLink provided by the sponsor.
- Ferndale Pharma GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Nestor, MD, PhD principal investigator
Director
Brian Berman, MD, PhD study chair
Co-director
Julie A Santos, PA-C, CRC study chair
Study Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DerMend Moisturizing Bruise Formula in people with Purpura, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Bruising (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.