Clinical trial NCT03103893: Novel Compositions for Treating or Preventing Dermal Disorders
Official title: Novel Compositions for Treating or Preventing Dermal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dermal Atrophy
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Dermal thickness
timeFrame: 6-8 months
Secondary outcomes:
measure: Gene expression
timeFrame: 6-8 months
measure: Seborrheic Keratosis
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel Dermatology
state: Pennsylvania
Study officials:
affiliation: Faculty member
name: Christian Sell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drexel University College of Medicine
name: Christina Chung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drexel University College of Medicine
name: Ibiyonu Lawrence, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.