AgingPhase 1NCT03072485
Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers
A Phase 1 study testing Sirolimus, Metformin and Diclofenac in people with Aging, run by Anne Chang at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Sirolimus, Metformin and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 22 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Dermatology
Redwood City, California, 94603
About this study
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.
Read the 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
- Keywords
- aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Topical sirolimus applied to the skin
MetforminDrug
Topical metformin applied to the skin
DiclofenacDrug
Topical diclofenac applied to the skin
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus, metformin, diclofenac | Other | First five enrolled participants Receives: Drug: Sirolimus; Drug: Metformin; Drug: Diclofenac |
| Metformin, diclofenac | Other | Sixth to tenth enrolled participants Receives: Drug: Metformin; Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of gene transcript changes
Profile of gene transcript changes
Measured: 4 weeks
Secondary outcomes (1)
Wrinkle score
on Likert scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Mar 2017
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Chang, Stanford University
- Investigators
- Anne Chang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072485
- Sponsor's protocol ID
- IRB-37203
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03072485
- Acronym / sponsor ID
- IRB-37203
- Conditions
- Aging
- Keywords
- aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Anne ChangUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus, metformin, diclofenac | Other | Drug: Sirolimus, Drug: Metformin, Drug: DiclofenacFirst five enrolled participants |
| Metformin, diclofenac | Other | Drug: Metformin, Drug: DiclofenacSixth to tenth enrolled participants |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusTopical sirolimus applied to the skin | Drug | Sirolimus, metformin, diclofenac |
| MetforminTopical metformin applied to the skin | Drug | Metformin, diclofenac, Sirolimus, metformin, diclofenac |
| DiclofenacTopical diclofenac applied to the skin | Drug | Metformin, diclofenac, Sirolimus, metformin, diclofenac |
Primary outcome
Profile of gene transcript changes
Time frame: 4 weeks
Profile of gene transcript changes
1 secondary outcome
Wrinkle score
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Chang, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sirolimus, Metformin and Diclofenac in people with Aging, run by Anne Chang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of gene transcript changes (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.