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Novel Compositions for Treating or Preventing Dermal Disorders

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

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rapamycin
Rapamycin
 Drug: Rapamycin
topical formulation
Other Name: sirolimus


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103893


Contacts
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Contact: Christian Sell, PhD 215-762-3944 hrpp@drexel.edu
Contact: Christina Chung, MD

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

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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03103893    
Other Study ID Numbers: 1604004478
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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