A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment of Senile Purpura
Information source: Multispecialty Aesthetic Clinical Research Organization
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Senile Purpura
Intervention: adapalene gel 0.3% (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Multispecialty Aesthetic Clinical Research Organization Official(s) and/or principal investigator(s):
Douglas Hamilton, MD, Principal Investigator, Affiliation: Multispecialty Aesthetic Clinical Research Organization
Overall contact:
Ronnie Zocks, BS, Phone: (310) 963-5001, Email: macroclinicaltrials@gmail.com
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.
Clinical Details
Official title: Phase II Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in The Prevention and Treatment of Senile Purpura
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura
Detailed description:
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.
Eligibility
Minimum age: 52 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 in another clinical trial with exposure to any investigational agent
within 30 days prior to Screening Visit.
- Any condition the Investigator believes would interfere with subject's ability to
provide informed consent, comply with study instruction, or which might confound the
interpretation of the study results or put the subject at undue risk.
- Subject is pregnant, breastfeeding or planning a pregnancy during the study.
- Subject is unable to communicate or cooperate with the Investigator due to a language
barrier (non-English speaking).
- Subjects who are allergic to adapalene or the ingredients in the gel.
Locations and Contacts
Ronnie Zocks, BS, Phone: (310) 963-5001, Email: macroclinicaltrials@gmail.com
Multispecialty Aesthetic Clinical Research Organization, Woodland Hills, California 91367, United States; Recruiting
Ronnie Zocks, BS, Phone: 310-963-5001, Email: macroclinicaltrials@gmail.com
Douglas Hamilton, MD, Principal Investigator
Multispecialty Aesthetic Clinical Research Organization, Woodland Hills, California 91367, United States; Recruiting
Ronnie Zocks, BS, Phone: 310-963-5001, Email: macroclinicaltrials@gmail.com
Additional Information
Starting date: December 2011
Last updated: April 19, 2012
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