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

NCT01485367 | Unknown Phase 2 DMC

• 1 other identifier: AD3001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Keywords

Senile Purpura; Adapalene 0.3%

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Adapalene gel 0.3%

ACTIVE COMPARATOR

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%

Adapalene gel 0.3 %

ACTIVE COMPARATOR

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%

Interventions

adapalene gel 0.3% DRUG

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.

Also known as: Differin gel 0.3%

Adapalene gel 0.3 %; Adapalene gel 0.3%

Eligibility Criteria

• Age: 52 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Multispecialty Aesthetic Clinical Research Organization: lead
• Galderma R&D: collaborator

Study Sites (2)

Multispecialty Aesthetic Clinical Research Organization

Woodland Hills, California, 91367, United States

RECRUITING

Multispecialty Aesthetic Clinical Research Organization

Woodland Hills, California, 91367, United States

RECRUITING

Study Officials

• Douglas Hamilton, MD

  Multispecialty Aesthetic Clinical Research Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronnie Zocks, BS

CONTACT

(310) 963-5001; macroclinicaltrials@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: December 5, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

US (2)