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

Senile Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01485367
• Other study ID #: AD3001
• Status: Recruiting
• Phase: Phase 2
• First received: November 17, 2011
• Last updated: April 19, 2012
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Multispecialty Aesthetic Clinical Research Organization
• Contact: Ronnie Zocks, BS
• Phone: (310) 963-5001
• Email: macroclinicaltrials[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 52 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura
• Senile Purpura

Intervention

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.

Locations

Country	Name	City	State
United States	Multispecialty Aesthetic Clinical Research Organization	Woodland Hills	California
United States	Multispecialty Aesthetic Clinical Research Organization	Woodland Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Multispecialty Aesthetic Clinical Research Organization	Galderma Laboratories, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes