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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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This is an open label 6 month pilot study for male and female participants over the age of 52 that desire treatment and prevention of senile purpura of the forearms.
This study will be evaluating the effects of Adapalene 0.3% for the use in the treatment and prevention of senile purpura.
This is a new potential use for the product Adapalene 0.3%, which is currently an FDA approved topical treatment used for the treatment of acne.
Senile purpura is a common sign of aging that appears in the form of dark blotches on the skin and is caused by bruising.
Older adults tend to be more prone to bruising, since as people age, their skin becomes thinner and more fragile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene gel 0.3% | Active Comparator | All odd numbered subjects will receive treatment to the left arm. The untreated arm will serve as an intrapatient control and will be evaluated separately from the treated arm for signs of purpura. |
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| Adapalene gel 0.3 % | Active Comparator | All even numbered subjects will receive treatment to the right arm. The untreated arm will serve as an intrapatient control and will be evaluated separately from the treated arm for signs of purpura. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapalene gel 0.3% | Drug | A pea size drop of Adapalene gel 0.3% will be applied to the odd numbered subjects on the left dorsal hand & extensor forearm. A pea size drop of Adapalene gel 0.3% will be applied to the even numbered subjects on the right dorsal hand & extensor forearm. The randomized area will be cleansed with Cetaphil Gentle Cleanser before applying the study medication. All subjects will apply sunscreen with zinc oxide in the morning to both the right & left forearms. |
| Measure | Description | Time Frame |
|---|---|---|
| Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura | To evaluate and document the degree of aesthetic results of subjects with senile purpura using the MACRO MD Purpura Lesion Assessment Scale | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronnie Zocks, BS | Contact | (310) 963-5001 | macroclinicaltrials@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Douglas Hamilton, MD | Multispecialty Aesthetic Clinical Research Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multispecialty Aesthetic Clinical Research Organization | Recruiting | Woodland Hills | California | 91367 | United States |
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| Multispecialty Aesthetic Clinical Research Organization | Recruiting | Woodland Hills | California | 91367 | United States |
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