Novel Compositions for Treating or Preventing Dermal Disorders

Dermal Atrophy Clinical Trial

Official title:

Novel Compositions for Treating or Preventing Dermal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103893
• Other study ID #: 1604004478
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 25, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: September 2021
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Dermal Atrophy

Intervention

Drug:
• Rapamycin
topical formulation

Locations

Country	Name	City	State
United States	Drexel Dermatology	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermal thickness	dermal thickness as assessed by direct measurement	6-8 months
Secondary	Gene expression	immunohistochemistry and gene expression analysis	6-8 months
Secondary	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