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

Primary Purpose

Senile Purpura

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

adapalene gel 0.3%

About this trial

This is an interventional treatment trial for Senile Purpura focused on measuring Senile Purpura, Adapalene 0.3%

Eligibility Criteria

52 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Multispecialty Aesthetic Clinical Research OrganizationRecruiting
Multispecialty Aesthetic Clinical Research OrganizationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Adapalene gel 0.3%

Adapalene gel 0.3 %

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01485367

First Posted

November 17, 2011

Last Updated

April 19, 2012

Sponsor

Multispecialty Aesthetic Clinical Research Organization

Collaborators

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT01485367

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Multispecialty Aesthetic Clinical Research Organization

Collaborators

Galderma R&D

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Senile Purpura

Keywords

Senile Purpura, Adapalene 0.3%

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adapalene gel 0.3%

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Adapalene gel 0.3 %

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

adapalene gel 0.3%

Other Intervention Name(s)

Differin gel 0.3%

Intervention Description

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 Information:

Title

Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura

Description

To evaluate and document the degree of aesthetic results of subjects with senile purpura using the MACRO MD Purpura Lesion Assessment Scale

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

52 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ronnie Zocks, BS

Phone

(310) 963-5001

macroclinicaltrials@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Douglas Hamilton, MD

Organizational Affiliation

Multispecialty Aesthetic Clinical Research Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Multispecialty Aesthetic Clinical Research Organization

City

Woodland Hills

State/Province

California

ZIP/Postal Code

91367

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronnie Zocks, BS

Phone

310-963-5001

macroclinicaltrials@gmail.com

First Name & Middle Initial & Last Name & Degree

Douglas Hamilton, MD

Facility Name

Multispecialty Aesthetic Clinical Research Organization

City

Woodland Hills

State/Province

California

ZIP/Postal Code

91367

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronnie Zocks, BS

Phone

310-963-5001

macroclinicaltrials@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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