NCT03072485

Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Anne Chang · Academic / Other
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 study in healthy adult volunteers to examine the effects of 3 FDA approved medications on skin aging when applied in topical form. This is an open label, placebo controlled study.

Detailed description

The primary endpoint of the study is the profile of differences in transcript levels of age-associated genes such as those in the lamin-A, insulin like growth factor (IGF) and NFKB pathways as well as noncoding RNAs in topical agent-exposed arm skin versus placebo exposed arm skin in healthy volunteers. The secondary endpoints include (1) differences in skin wrinkling using a 4 point Likert scale for wrinkle severity between placebo and topical agent exposed arm skin after 4 weeks of usage; (2) the type and severity of adverse events, both systemic and skin localized after exposure to both topical agent and placebo vehicle cream.

Conditions

• Aging

Interventions

Type	Name	Description
DRUG	Sirolimus	Topical sirolimus applied to the skin
DRUG	Metformin	Topical metformin applied to the skin
DRUG	Diclofenac	Topical diclofenac applied to the skin

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-02-22
• Completion: 2019-02-22
• First posted: 2017-03-07
• Last updated: 2019-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study