Senile PurpuraPhase 2NCT01485367
A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment of Senile Purpura
A Phase 2 study testing adapalene gel 0.3% in people with Senile Purpura, run by Multispecialty Aesthetic Clinical Research Organization at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 52 years and olderHealthy volunteers can take part
- Conditions the study is for
- Senile Purpura
- What is being tested?
- adapalene gel 0.3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Multispecialty Aesthetic Clinical Research Organization
Woodland Hills, California, 91367
Ronnie Zocks, BS, 310-963-5001, macroclinicaltrials@gmail.com
Douglas Hamilton, MD
- Recruiting
Multispecialty Aesthetic Clinical Research Organization
Woodland Hills, California, 91367
Ronnie Zocks, BS, 310-963-5001, macroclinicaltrials@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Senile Purpura
- Being tested
- adapalene gel 0.3%
- Keywords
- Senile Purpura, Adapalene 0.3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapalene gel 0.3%Drug
Also called Differin 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: adapalene gel 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senile PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multispecialty Aesthetic Clinical Research Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
- Investigators
- Douglas Hamilton, MD, Principal investigator, Multispecialty Aesthetic Clinical Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485367
- Sponsor's protocol ID
- AD3001
- Status last verified
- Apr 2012
- First submitted
- 17 Nov 2011
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in The Prevention and Treatment of Senile Purpura
- ClinicalTrials.gov ID
- NCT01485367
- Acronym / sponsor ID
- AD3001
- Conditions
- Senile Purpura
- Keywords
- Senile Purpura, Adapalene 0.3%
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Multispecialty Aesthetic Clinical Research OrganizationUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapalene gel 0.3% | Active comparator | Drug: 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. |
| Adapalene gel 0.3 % | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 52 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adapalene gel 0.3%Also: Differin 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. | Drug | Adapalene gel 0.3 %, Adapalene gel 0.3% |
Primary outcome
Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura
Time frame: Up to 6 months
To evaluate and document the degree of aesthetic results of subjects with senile purpura using the MACRO MD Purpura Lesion Assessment Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Hamilton, MD principal investigator
Multispecialty Aesthetic Clinical Research Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adapalene gel 0.3% in people with Senile Purpura, run by Multispecialty Aesthetic Clinical Research Organization at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronnie Zocks, BS ((310) 963-5001, macroclinicaltrials@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Show the clinical benefit of daily application of Adapalene 0.3% in decreasing the signs of senile purpura (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012.