Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Anne Chang
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Profile of gene transcript changes
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age greater than or equal to 55 years
- •All 4 grandparents of European descent
- •Fitzpatrick Skin type 1-3 (fair skin type)
- •Presence of moderate to severe fine wrinkling on arm skin
- •Presence of moderate to severe dyspigmentation on arm skin
- •Normal or overweight body mass index
Exclusion Criteria
- •History of laser treatment or chemical peels to to arm
- •History of topical anti-aging products (includes retinol, tretinoin, tazarotene, azelaic acid, hydroquinone) to skin within 6 weeks of starting study
- •History of surgical procedures to arm skin area including removal of benign or malignant skin cancers in the area of topical study agent application
- •Current skin conditions in the area of arms including seborrheic keratosis, rosacea, eczema that may obscure study assessment
- •History of abnormal scarring
- •Uncontrolled medical problems including concurrent infection or malignancy at time of enrollment
- •Unable to provide and sign written informed consent
- •Unable to comply with study-related procedures including keeping study diary, application of topical study agents, avoidance of direct sun exposure \>5 minutes per day or ultraviolet tanning bed usage
- •Not willing to provide two small skin biopsies at end of study
- •Known allergy to sirolimus, diclofenac or metformin.
Arms & Interventions
Sirolimus, metformin, diclofenac
First five enrolled participants
Intervention: Diclofenac (Drug)
Sirolimus, metformin, diclofenac
First five enrolled participants
Intervention: Metformin (Drug)
Sirolimus, metformin, diclofenac
First five enrolled participants
Intervention: Sirolimus (Drug)
Metformin, diclofenac
Sixth to tenth enrolled participants
Intervention: Metformin (Drug)
Metformin, diclofenac
Sixth to tenth enrolled participants
Intervention: Diclofenac (Drug)
Outcomes
Primary Outcomes
Profile of gene transcript changes
Time Frame: 4 weeks
Profile of gene transcript changes
Secondary Outcomes
- Wrinkle score(4 weeks)
Investigators
Anne Chang
Associate Professor
Stanford University