Novel Compositions for Treating or Preventing Dermal Disorders

NCT03103893 | Completed Phase 1 FDA Drug

• 1 other identifier: 1604004478
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dermal Atrophy

Outcome Measures

Primary Outcomes (1)

• Dermal thickness

  dermal thickness as assessed by direct measurement

  6-8 months

Secondary Outcomes (2)

• Gene expression

  6-8 months

• Seborrheic Keratosis

  6-8 months

Study Arms (1)

Rapamycin

EXPERIMENTAL

Rapamycin

Drug: Rapamycin

Interventions

Rapamycin DRUG

topical formulation

Also known as: sirolimus

Rapamycin

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel Dermatology

Philadelphia, Pennsylvania, 19102-1101, United States

Location

Related Publications (1)

• 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.

  PMID: 31761958 DERIVED

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Clinical assessors are blinded to recruitment and treatment assignment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 6, 2017
• Study Start: September 25, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)