Novel Compositions for Treating or Preventing Dermal Disorders
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 40 - 100 |
| Updated: | 10/26/2017 |
| Start Date: | September 25, 2017 |
| End Date: | June 30, 2019 |
| Contact: | Christian Sell, PhD |
| Email: | hrpp@drexel.edu |
| Phone: | 215-762-3944 |
This trial examines the impact of a topical formulation of rapamycin on dermal thickness and
senescence.
senescence.
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.
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.
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)
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