Novel Compositions for Treating or Preventing Dermal Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2017-11-30

Brief Summary

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This trial examines the impact of a topical formulation of rapamycin on dermal thickness and senescence.

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Detailed Description

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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

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Dermal Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Clinical assessors are blinded to recruitment and treatment assignment.

Study Groups

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Rapamycin

Group Type EXPERIMENTAL

Rapamycin

Intervention Type DRUG

topical formulation

Interventions

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Rapamycin

topical formulation

Intervention Type DRUG

Other Intervention Names

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sirolimus

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes