Dermal AtrophyPhase 1/2NCT03103893
Novel Compositions for Treating or Preventing Dermal Disorders
A Phase 1/2 study testing Rapamycin in people with Dermal Atrophy, run by Drexel University at 1 site in United States.
Trial summary
This trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermal Atrophy
- What is being tested?
- Rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 30 Nov 2017
- Phase
- Phase 1/2
- 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 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Individuals with any chronic disease will be excluded from the study including those with the following conditions:
- Diabetes
- Any type of Malignancy
- Severe coronary artery disease
- HIV infection
- Hepatitis C or B
Show all 18Show fewer
- Any sign of skin disorder or disease aside from normal aging, dermal atrophy, or seborrheic keratoses.
- Premenopausal women will be excluded
- Patients taking the following medications will be excluded:
- Cyclosporin
- Calcium channel blockers: diltiazem, verapamil
- Antifungal agents e.g. clotrimazole, fluconazole, itraconazole
- Antibiotics: clarithromycin, erythromycin, rifampicin
- Anticonvulsants: carbamazepine, phenobarbitone, phenytoin
- Antinausea drugs e.g. metoclopramide
- Other drugs e.g. danazol, protease inhibitors (e.g. for HIV and hepatitis C including ritonavir, indinavir, boceprevir, and telaprevir)
- Grapefruit juice
- St John's wort (Hypericum perforatum, hypericin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel Dermatology
Philadelphia, Pennsylvania, 19102-1101
About this study
This trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.
Read the detailed description
Aging of the skin is the most prominent feature of the aging process, being caused by multiple factors such as intrinsic aging process and UV light exposure.
Dermal atrophy, also called skin atrophy or atrophy, is a disorder manifesting thinning or depression of skin due to reduction of underlying tissue. Dermal atrophy is a major clinical problem in the elderly population. Loss of dermal integrity leads to increased fragility of the skin and precludes the use of intravenous lines in many cases. Skin tears are a significant concern in elderly individuals directly related to dermal atrophy. Impairment in wound healing is an important clinical sequelae of reduced dermal integrity leading to an increase in the number of the infections and complications following injury. Seborrheic keratosis, which comprise focal areas of epidermal thickening, can occur, possibly representing a response to damage. It has been estimated that 100% of individuals over 50 years of age harbor at least one of these lesion. There is not treatment for dermal atrophy and seborrheic keritoses require excision if they become large enough to cause discomfort or distress.
Therefore, there is a need to develop novel compositions and methods for treating or preventing certain age-related dermal conditions.
Rapamycin is an FDA approved drug that has been in clinical use for over 15 years. Systemic application of rapamycin has been a central part of immuno suppressive therapy for transplant patients in combination with other immuno suppressants. The safety record for systemic use of rapamycin is excellent and few side effects are associated with extended use.
- Conditions
- Dermal Atrophy
- Being tested
- Rapamycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called sirolimus
topical formulation
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin | Experimental | Rapamycin Receives: Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal thickness
dermal thickness as assessed by direct measurement
Measured: 6-8 months
Secondary outcomes (2)
Gene expression
immunohistochemistry and gene expression analysis
Measured: 6-8 months
Seborrheic Keratosis
clinical severity will be assess using a 1-5 rating scale of severity. Lesions will be evaluated for their progression over the treatment period relative to the known course of growth for Seborrheic Keratoses.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start25 Sep 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermal AtrophyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Sell, PhD, Principal investigator, Faculty memberChristina Chung, MD, Principal investigator, Drexel University College of MedicineIbiyonu Lawrence, MD, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103893
- Sponsor's protocol ID
- 1604004478
- Status last verified
- Sep 2021
- First submitted
- 7 Mar 2017
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung CL, Lawrence I, Hoffman M, Elgindi D, Nadhan K, Potnis M, Jin A, Sershon C, Binnebose R, Lorenzini A, Sell C. Topical rapamycin reduces markers of senescence and aging in human skin: an exploratory, prospective, randomized trial. Geroscience. 2019 Dec;41(6):861-869. doi: 10.1007/s11357-019-00113-y. Epub 2019 Nov 25.
PubMed 31761958
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Compositions for Treating or Preventing Dermal Disorders
- ClinicalTrials.gov ID
- NCT03103893
- Acronym / sponsor ID
- 1604004478
- Conditions
- Dermal Atrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 6 Apr 2017 (actual)
- 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 trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.
Detailed description
Aging of the skin is the most prominent feature of the aging process, being caused by multiple factors such as intrinsic aging process and UV light exposure.
Dermal atrophy, also called skin atrophy or atrophy, is a disorder manifesting thinning or depression of skin due to reduction of underlying tissue. Dermal atrophy is a major clinical problem in the elderly population. Loss of dermal integrity leads to increased fragility of the skin and precludes the use of intravenous lines in many cases. Skin tears are a significant concern in elderly individuals directly related to dermal atrophy. Impairment in wound healing is an important clinical sequelae of reduced dermal integrity leading to an increase in the number of the infections and complications following injury. Seborrheic keratosis, which comprise focal areas of epidermal thickening, can occur, possibly representing a response to damage. It has been estimated that 100% of individuals over 50 years of age harbor at least one of these lesion. There is not treatment for dermal atrophy and seborrheic keritoses require excision if they become large enough to cause discomfort or distress.
Therefore, there is a need to develop novel compositions and methods for treating or preventing certain age-related dermal conditions.
Rapamycin is an FDA approved drug that has been in clinical use for over 15 years. Systemic application of rapamycin has been a central part of immuno suppressive therapy for transplant patients in combination with other immuno suppressants. The safety record for systemic use of rapamycin is excellent and few side effects are associated with extended use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.
| Arm | Type | Receives |
|---|---|---|
| Rapamycin | Experimental | Drug: RapamycinRapamycin |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (18 listed)
- Individuals with any chronic disease will be excluded from the study including those with the following conditions:
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 |
|---|---|---|
| RapamycinAlso: sirolimustopical formulation | Drug | Rapamycin |
Primary outcome
Dermal thickness
Time frame: 6-8 months
dermal thickness as assessed by direct measurement
2 secondary outcomes
Gene expression
Time frame: 6-8 months
Seborrheic Keratosis
Time frame: 6-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 31761958Chung CL, Lawrence I, Hoffman M, Elgindi D, Nadhan K, Potnis M, Jin A, Sershon C, Binnebose R, Lorenzini A, Sell C. Topical rapamycin reduces markers of senescence and aging in human skin: an exploratory, prospective, randomized trial. Geroscience. 2019 Dec;41(6):861-869. doi: 10.1007/s11357-019-00113-y. Epub 2019 Nov 25.
- Individual participant dataSharing planned: No
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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.
Christian Sell, PhD principal investigator
Faculty member
Christina Chung, MD principal investigator
Drexel University College of Medicine
Ibiyonu Lawrence, MD principal investigator
Drexel University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rapamycin in people with Dermal Atrophy, run by Drexel University at 1 site 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 1 inclusion and 18 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: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal thickness (time frame: 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03103893, which also lists 1 linked publication.
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 22 Sep 2021.