NCT03072485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

February 27, 2017

Last Update Submit

March 28, 2019

Conditions

Aging

Keywords

aging

Outcome Measures

Primary Outcomes (1)

  • Profile of gene transcript changes

    Profile of gene transcript changes

    4 weeks

Secondary Outcomes (1)

  • Wrinkle score

    4 weeks

Study Arms (2)

Sirolimus, metformin, diclofenac

OTHER

First five enrolled participants

Drug: SirolimusDrug: MetforminDrug: Diclofenac

Metformin, diclofenac

OTHER

Sixth to tenth enrolled participants

Drug: MetforminDrug: Diclofenac

Interventions

SirolimusDRUG

Topical sirolimus applied to the skin

Sirolimus, metformin, diclofenac
MetforminDRUG

Topical metformin applied to the skin

Metformin, diclofenacSirolimus, metformin, diclofenac
DiclofenacDRUG

Topical diclofenac applied to the skin

Metformin, diclofenacSirolimus, metformin, diclofenac

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 55 years
  • Female
  • 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

You may not qualify if:

  • 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.
  • Known immunosuppression including organ transplant, HIV, autoimmune disease, and chronic leukemia or lymphoma
  • Fasting blood sugar above the upper limit of normal for Stanford laboratory
  • Diarrhea
  • Use of greater than one alcoholic beverage per day
  • Stress such as surgery or trauma within 2 weeks of enrollment
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Dermatology

Redwood City, California, 94603, United States

Location

MeSH Terms

Interventions

SirolimusMetforminDiclofenac

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsBiguanidesGuanidinesAmidinesPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Anne Chang, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 7, 2017

Study Start

March 1, 2017

Primary Completion

February 22, 2019

Study Completion

February 22, 2019

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)