A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment … (NCT01485367) | Clinical Trial Compass
UnknownPhase 2
A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment of Senile Purpura
United States20 participantsStarted 2011-12
Plain-language summary
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.
Who can participate
Age range52 Years
SexALL
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Inclusion Criteria:
* Male or female over 52 years of age with signs of senile purpura on either the right or left (or both) dorsal hand \& extensor forearm and desire treatment for this condition that is associated with aging.
* Women who have had hysterectomies, tubal ligations or who are post-menopausal for at least one year prior to the study may be enrolled. Women of childbearing potential who are not pregnant, not planning to become pregnant during the study period, and not lactating may be enrolled if they are using a medically accepted contraceptive program initiated at least one month prior to study entry and continued during the study.
* Subject is willing to comply with study instructions and return to the clinic for required visits.
* Subject is able to understand and has signed an IRB approved informed consent form including consent for photography.
Exclusion Criteria:
* All subjects on coumadin, heparin, plavix, supplemental herbs, vitamin E, empirin, fiorinal, norgesic, forte, percodan, robaxin, nuprin, ansaid, anaprox, clinoril, dolobid, feldene, naprosyn, voltaren, fish oil, oral steroids, or daily use of aspirin, Motrin, or Advil. (PRN usage not excluded)
* Prior treatment with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids within 3 months of study enrollment is prohibited.
* Clotting abnormalities as determined by screening labs
* Any history of a stroke or unstable heart disease
* Participation…
What they're measuring
1
Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura
Timeframe: Up to 6 months
Trial details
NCT IDNCT01485367
SponsorMultispecialty Aesthetic Clinical Research Organization