Recruiting
Phase 2

Adapalene

Sponsor:

Multispecialty Aesthetic Clinical Research Organization

Code:

NCT01485367

Conditions

Senile Purpura

Eligibility Criteria

Sex: All

Age: 52+

Healthy Volunteers: Accepted

Interventions

adapalene gel 0.3%

Study Details

Brief 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.

Conditions

Senile Purpura

Study ID

NCT01485367

Start date

Dec, 2011

Status verified date

Apr, 2012

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 52+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Adapalene gel 0.3%

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.

active comparator: Adapalene gel 0.3 %

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.

Interventions

adapalene gel 0.3%

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.

Primary outcome measure

  • Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Ronnie Zocks, BS

(310) 963-5001macroclinicaltrials@gmail.com

Locations

Multispecialty Aesthetic Clinical Research Organization

Recruiting

Woodland Hills, California, United States, 91367

Contacts

Ronnie Zocks, BS

310-963-5001macroclinicaltrials@gmail.com

Principal Investigator:

Douglas Hamilton, MD

Multispecialty Aesthetic Clinical Research Organization

Recruiting

Woodland Hills, California, United States, 91367

Contacts

Ronnie Zocks, BS

310-963-5001macroclinicaltrials@gmail.com

More Information

Sponsor

Multispecialty Aesthetic Clinical Research Organization

Last update posted

Apr 23, 2012

Last verified

Apr, 2012

Keywords

  • Senile Purpura
  • Adapalene 0.3%

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Multispecialty Aesthetic Clinical Research Organization on 2012-04-23.