Novel Compositions for Treating or Preventing Dermal Disorders

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

Study Overview

• Status: Completed
• Conditions: Dermal Atrophy
• Intervention / Treatment: Drug: Rapamycin

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102-1101
      • Drexel Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapamycin	Drug: Rapamycin; topical formulation; Other Names: sirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermal thickness	dermal thickness as assessed by direct measurement	6-8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression	immunohistochemistry and gene expression analysis	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.	6-8 months

Collaborators and Investigators

• Sponsor: Drexel University
• Investigators: Principal Investigator: Christian Sell, PhD, Faculty Member; Principal Investigator: Christina Chung, MD, Drexel University College of Medicine; Principal Investigator: Ibiyonu Lawrence, MD, Drexel University College of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 1604004478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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