Novel Compositions for Treating or Preventing Dermal Disorders
Primary Purpose
Dermal Atrophy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rapamycin
Sponsored by
About this trial
This is an interventional treatment trial for Dermal Atrophy
Eligibility Criteria
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
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
- 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)
Sites / Locations
- Drexel Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rapamycin
Arm Description
Rapamycin
Outcomes
Primary Outcome Measures
Dermal thickness
dermal thickness as assessed by direct measurement
Secondary Outcome Measures
Gene expression
immunohistochemistry and gene expression analysis
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03103893
Brief Title
Novel Compositions for Treating or Preventing Dermal Disorders
Official Title
Novel Compositions for Treating or Preventing Dermal Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.
Masking
None (Open Label)
Masking Description
Clinical assessors are blinded to recruitment and treatment assignment.
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapamycin
Arm Type
Experimental
Arm Description
Rapamycin
Intervention Type
Drug
Intervention Name(s)
Rapamycin
Other Intervention Name(s)
sirolimus
Intervention Description
topical formulation
Primary Outcome Measure Information:
Title
Dermal thickness
Description
dermal thickness as assessed by direct measurement
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Gene expression
Description
immunohistochemistry and gene expression analysis
Time Frame
6-8 months
Title
Seborrheic Keratosis
Description
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.
Time Frame
6-8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Sell, PhD
Organizational Affiliation
Faculty member
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christina Chung, MD
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ibiyonu Lawrence, MD
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31761958
Citation
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.
Results Reference
derived
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Novel Compositions for Treating or Preventing Dermal Disorders
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