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

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

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.

Study Overview

• Status: Unknown
• Conditions: Senile Purpura
• Intervention / Treatment: Drug: adapalene 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ronnie Zocks, BS; Phone Number: (310) 963-5001; Email: macroclinicaltrials@gmail.com

Study Locations

• United States
  • California
    • Woodland Hills, California, United States, 91367
      • Recruiting
      • Multispecialty Aesthetic Clinical Research Organization
      • Contact: Ronnie Zocks, BS; Phone Number: 310-963-5001; Email: macroclinicaltrials@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 52 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Differin gel 0.3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura	To evaluate and document the degree of aesthetic results of subjects with senile purpura using the MACRO MD Purpura Lesion Assessment Scale	Up to 6 months

Collaborators and Investigators

• Sponsor: Multispecialty Aesthetic Clinical Research Organization
• Collaborators: Galderma R&D
• Investigators: Principal Investigator: Douglas Hamilton, MD, Multispecialty Aesthetic Clinical Research Organization

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: November 17, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2012
• Last Update Submitted That Met QC Criteria: April 19, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Senile Purpura; Adapalene 0.3%
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Purpura; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Adapalene
• Other Study ID Numbers: AD3001