Novel Compositions for Treating or Preventing Dermal Disorders

• ClinicalTrials.gov Identifier: NCT03103893
• Recruitment Status: Unknown
• First Posted: April 6, 2017
• Last Update Posted: October 24, 2017
• Sponsor: Drexel University
• Information provided by (Responsible Party): Drexel University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Dermal Atrophy	Drug: Rapamycin	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Intervention Model: Single Group Assignment
• Intervention 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.
• Primary Purpose: Treatment
• Official Title: Novel Compositions for Treating or Preventing Dermal Disorders
• Actual Study Start Date: September 25, 2017
• Estimated Primary Completion Date: November 30, 2018
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Rapamycin; Rapamycin	Drug: Rapamycin; topical formulation; Other Name: sirolimus

Outcome Measures

Primary Outcome Measures :

1. Dermal thickness [ Time Frame: 6-8 months ]
   dermal thickness as assessed by direct measurement

Secondary Outcome Measures :

1. Gene expression [ Time Frame: 6-8 months ]
   immunohistochemistry and gene expression analysis
2. Seborrheic Keratosis [ Time Frame: 6-8 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Contacts

Contact: Christian Sell, PhD; 215-762-3944; hrpp@drexel.edu

Contact: Christina Chung, MD

Locations

United States, Pennsylvania

Drexel Dermatology; Recruiting

Philadelphia, Pennsylvania, United States, 19102-1101

Contact: Christina Chung, MD 215-762-5546 christina.chung@drexelmed.edu

Contact: Christian Sell 2157628367 cs389@drexel.edu

Sub-Investigator: Ibyonu Lawrence, MD

Sponsors and Collaborators

Drexel University

Investigators

• Principal Investigator: Christian Sell, PhD; Faculty member
• Principal Investigator: Christina Chung, MD; Drexel University College of Medicine
• Principal Investigator: Inyonu Lawrence, MD; Drexel University College of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Nov 25. doi: 10.1007/s11357-019-00113-y. [Epub ahead of print]

• Responsible Party: Drexel University
• ClinicalTrials.gov Identifier: NCT03103893 History of Changes
• Other Study ID Numbers: 1604004478
• First Posted: April 6, 2017
• Last Update Posted: October 24, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Atrophy; Pathological Conditions, Anatomical; Sirolimus; Everolimus; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs