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

Completed · Phase 1

Conditions studied: Aging

In brief

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.

Key facts

Study ID

NCT03072485

Run by

Anne Chang

People needed

10

Starts

2017-03-01

Expected to finish

2019-02-22

Last updated by the study team

2019-04-01

Who can join

Age: 55 and older. Sex: female. Healthy volunteers: accepted.

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
• Liver disease such as hepatitis B or C
• Planning to embark on dieting, caloric restriction or new exercise regimen during the study to lose weight.
• Unable to refrain from using any topical agent on arms besides the study agents provided for duration of study.
• Hematocrit, hemoglobin, platelets, white blood cell count, serum Na, K, Cr, aspartate aminotransferase (AST), alanine aminotransferase (ALT) greater or lesser than 1.5 times limits of normal.
• History of heart failure, coronary artery disease, including angina, coronary artery bypass graft, pacemaker or stent placement
• History of bleeding or ulcers of the gastrointestinal tract
• History of diabetes mellitus
• Current use of blood thinners (includes heparin, warfarin and aspirin)
• Current use of strong cytochrome P 450 (CYP) 3A4 inhibitor and/or P-gp (examples include ketoconazole, voriconazole, itraconazole, erythromycin, clarithromycin) or strong inducers of CYP3A4 and/or P-gp (examples include rifampin or rifabutin)
• Abnormal lipid panel as defined by upper limit of normal at Stanford laboratory

Where it is running

• Stanford Dermatology — Redwood City, California, United States

Full record on ClinicalTrials.gov

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