A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment of Senile Purpura

Last updated: April 19, 2012
Sponsor: Multispecialty Aesthetic Clinical Research Organization
Overall Status: Trial Status Unknown

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01485367
AD3001
  • Ages > 52
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female over 52 years of age with signs of senile purpura on either the rightor left (or both) dorsal hand & extensor forearm and desire treatment for thiscondition that is associated with aging.

  • Women who have had hysterectomies, tubal ligations or who are post-menopausal for atleast one year prior to the study may be enrolled. Women of childbearing potential whoare not pregnant, not planning to become pregnant during the study period, and notlactating may be enrolled if they are using a medically accepted contraceptive programinitiated 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 forrequired visits.

  • Subject is able to understand and has signed an IRB approved informed consent formincluding consent for photography.

Exclusion

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 ofaspirin, Motrin, or Advil. (PRN usage not excluded)

  • Prior treatment with any systemic immunosuppressive therapy including but not limitedto chemotherapy agents or corticosteroids within 3 months of study enrollment isprohibited.

  • 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 agentwithin 30 days prior to Screening Visit.

  • Any condition the Investigator believes would interfere with subject's ability toprovide informed consent, comply with study instruction, or which might confound theinterpretation 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 languagebarrier (non-English speaking).

  • Subjects who are allergic to adapalene or the ingredients in the gel.

Study Design

Total Participants: 20
Study Start date:
December 01, 2011
Estimated Completion Date:
December 31, 2012

Study 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.

Connect with a study center

  • Multispecialty Aesthetic Clinical Research Organization

    Woodland Hills, California 91367
    United States

    Active - Recruiting

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