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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Multispecialty Aesthetic Clinical Research Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Galderma Laboratories, L.P.
Information provided by (Responsible Party):
Multispecialty Aesthetic Clinical Research Organization
ClinicalTrials.gov Identifier:
NCT01485367
First received: November 17, 2011
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Senile Purpura
Drug: adapalene gel 0.3%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in The Prevention and Treatment of Senile Purpura

Resource links provided by NLM:


Further study details as provided by Multispecialty Aesthetic Clinical Research Organization:

Primary Outcome Measures:
  • Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    To evaluate and document the degree of aesthetic results of subjects with senile purpura using the MACRO MD Purpura Lesion Assessment Scale


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
Other Name: Differin gel 0.3%
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.
Drug: 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.
Other Name: Differin gel 0.3%

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

Ages Eligible for Study:   52 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485367

Contacts
Contact: Ronnie Zocks, BS (310) 963-5001 macroclinicaltrials@gmail.com

Locations
United States, California
Multispecialty Aesthetic Clinical Research Organization Recruiting
Woodland Hills, California, United States, 91367
Contact: Ronnie Zocks, BS    310-963-5001    macroclinicaltrials@gmail.com   
Principal Investigator: Douglas Hamilton, MD         
Multispecialty Aesthetic Clinical Research Organization Recruiting
Woodland Hills, California, United States, 91367
Contact: Ronnie Zocks, BS    310-963-5001    macroclinicaltrials@gmail.com   
Sponsors and Collaborators
Multispecialty Aesthetic Clinical Research Organization
Galderma Laboratories, L.P.
Investigators
Principal Investigator: Douglas Hamilton, MD Multispecialty Aesthetic Clinical Research Organization
  More Information

No publications provided

Responsible Party: Multispecialty Aesthetic Clinical Research Organization
ClinicalTrials.gov Identifier: NCT01485367     History of Changes
Other Study ID Numbers: AD3001
Study First Received: November 17, 2011
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Multispecialty Aesthetic Clinical Research Organization:
Senile Purpura
Adapalene 0.3%

Additional relevant MeSH terms:
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014