Skin TearPhase 2/3NCT07084116
Evaluation of Tretinoin Cream on the Integrity of Aged Forearm Skin
A Phase 2/3 study testing Tretinoin 0.1% cream and Bland cream (non-drug) in people with Skin Tear and Solar Purpura, run by James Thomas Pathoulas at 1 site in United States.
Trial summary
The purpose of this research is to determine whether once nightly application of tretinoin 0.1% cream to forearm skin reduces the frequency of skin tears and bruising (solar purpura), and changes skin thickness over a period of 6 months. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Skin Tear, Solar Purpura, Dermatoporosis
- What is being tested?
- Tretinoin 0.1% cream and Bland cream (non-drug)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 24 May 2026
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (55+)
- History of skin tears, at least 2 in the past month
- History of skin bruising (solar purpura)
- Ambulatory
- Able to apply topical medication to oneself
Who cannot join
- <55 years old)
- Pregnant or breastfeeding
- History of allergy to tretinoin
- History of atopic dermatitis, psoriasis, bullous skin disease, cutaneous lupus, or cutaneous T cell lymphoma.
- Planned cutaneous surgery on either forearm in the next 6 months
- Use of any topical medication on the forearms within past month
Show all 11Show fewer
- Current or anticipated phototherapy of the forearms in the next 6 months
- Current or anticipated chemotherapy within the next 6 months
- Use of oral steroids within past month
- Current or prior isotretinoin therapy within past 6 months
- AV fistula of the arm
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto VA Medical Center
Palo Alto, California, 94304
About this study
Official title: Evaluation of Tretinoin Cream on the Integrity of Aged Forearm Skin: an Open-label Within-subject Randomized Study
The purpose of this research is to determine whether once nightly application of tretinoin 0.1% cream to forearm skin reduces the frequency of skin tears and bruising (solar purpura), and changes skin thickness over a period of 6 months.
Read the detailed description
Easy bruising and tearing of forearm skin is common with aging and can cause activity restriction, infection, and pain. Chronic exposure to UV light from the sun causes skin thinning and loss of supportive collagen over time. Thin skin tears easily and blood vessels normally protected by collagen rupture, causing bruises. Tretinoin is a prescription vitamin A cream that has been shown to increase skin thickness and collagen. Tretinoin is FDA approved for treatment of acne. We are trying to figure out if putting tretinoin cream on the forearms of adults with thin skin prevents skin tears and bruising.
We are looking for 30 people with a history of skin tears in the United States. The VA Palo Alto expects to enroll 30 research study subjects.
- Conditions
- Skin Tear, Solar Purpura, Dermatoporosis
- Being tested
- Tretinoin 0.1% cream, Bland cream (non-drug)
- Keywords
- skin tear, thin skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tretinoin 0.1% creamDrug
Also called Bland cream (non-medicated)
Tretinoin 0.1% cream formulation.
Bland cream (non-drug)Drug
Bland cream formulation.
| Study group | Role | What they receive |
|---|---|---|
| Arm participants apply tretinoin (LEFT or RIGHT) | Active comparator | Participants will apply tretinoin 0.1% cream nightly for 6 months. Receives: Drug: Tretinoin 0.1% cream; Drug: Bland cream (non-drug) |
| Arm participants apply bland cream (not treatment) (LEFT or RIGHT) | Placebo comparator | Participants apply bland cream to the other arm nightly as a placebo. Receives: Drug: Bland cream (non-drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of skin tears.
Measured: 6 months.
Change in epidermal (top layer of skin) thickness.
Measured: 6 months.
Secondary outcomes (1)
Change in percent of skin on the arms involved by solar purpura (bruising).
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start14 Jul 2025
- Primary completion23 May 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin TearStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will either apply the test cream (tretinoin 0.1% cream) to the right or left arm and a bland cream (placebo) to the other - they will be randomized to right or left arm based on handedness (dominant vs non-dominant).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Thomas Pathoulas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Thomas Pathoulas, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084116
- Sponsor's protocol ID
- 77594
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Restriction as part of monitoring agreement.
Publications
Sitohang IBS, Makes WI, Sandora N, Suryanegara J. Topical tretinoin for treating photoaging: A systematic review of randomized controlled trials. Int J Womens Dermatol. 2022 Mar 25;8(1):e003. doi: 10.1097/JW9.0000000000000003. eCollection 2022 Mar.
PubMed 35620028
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tretinoin Cream on the Integrity of Aged Forearm Skin: an Open-label Within-subject Randomized Study
- ClinicalTrials.gov ID
- NCT07084116
- Acronym / sponsor ID
- 77594
- Conditions
- Skin Tear, Solar Purpura, Dermatoporosis
- Keywords
- skin tear, thin skin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- James Thomas PathoulasUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 23 May 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 24 Jul 2025 (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.
The purpose of this research is to determine whether once nightly application of tretinoin 0.1% cream to forearm skin reduces the frequency of skin tears and bruising (solar purpura), and changes skin thickness over a period of 6 months.
Detailed description
Easy bruising and tearing of forearm skin is common with aging and can cause activity restriction, infection, and pain. Chronic exposure to UV light from the sun causes skin thinning and loss of supportive collagen over time. Thin skin tears easily and blood vessels normally protected by collagen rupture, causing bruises. Tretinoin is a prescription vitamin A cream that has been shown to increase skin thickness and collagen. Tretinoin is FDA approved for treatment of acne. We are trying to figure out if putting tretinoin cream on the forearms of adults with thin skin prevents skin tears and bruising.
We are looking for 30 people with a history of skin tears in the United States. The VA Palo Alto expects to enroll 30 research study subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will either apply the test cream (tretinoin 0.1% cream) to the right or left arm and a bland cream (placebo) to the other - they will be randomized to right or left arm based on handedness (dominant vs non-dominant).
| Arm | Type | Receives |
|---|---|---|
| Arm participants apply tretinoin (LEFT or RIGHT) | Active comparator | Drug: Tretinoin 0.1% cream, Drug: Bland cream (non-drug)Participants will apply tretinoin 0.1% cream nightly for 6 months. |
| Arm participants apply bland cream (not treatment) (LEFT or RIGHT) | Placebo comparator | Drug: Bland cream (non-drug)Participants apply bland cream to the other arm nightly as a placebo. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (55+)
- History of skin tears, at least 2 in the past month
- History of skin bruising (solar purpura)
- Ambulatory
- Able to apply topical medication to oneself
Key exclusion criteria (11 listed)
- <55 years old)
- Pregnant or breastfeeding
- History of allergy to tretinoin
- History of atopic dermatitis, psoriasis, bullous skin disease, cutaneous lupus, or cutaneous T cell lymphoma.
- Planned cutaneous surgery on either forearm in the next 6 months
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 |
|---|---|---|
| Tretinoin 0.1% creamAlso: Bland cream (non-medicated)Tretinoin 0.1% cream formulation. | Drug | Arm participants apply tretinoin (LEFT or RIGHT) |
| Bland cream (non-drug)Bland cream formulation. | Drug | Arm participants apply bland cream (not treatment) (LEFT or RIGHT), Arm participants apply tretinoin (LEFT or RIGHT) |
Primary outcome
Change in frequency of skin tears.
Time frame: 6 months.
Change in epidermal (top layer of skin) thickness.
Time frame: 6 months.
1 secondary outcome
Change in percent of skin on the arms involved by solar purpura (bruising).
Time frame: 6 months.
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 28 May 2026.
- Background: PubMed 35620028Sitohang IBS, Makes WI, Sandora N, Suryanegara J. Topical tretinoin for treating photoaging: A systematic review of randomized controlled trials. Int J Womens Dermatol. 2022 Mar 25;8(1):e003. doi: 10.1097/JW9.0000000000000003. eCollection 2022 Mar.
- Individual participant dataSharing planned: No. Restriction as part of monitoring agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tretinoin 0.1% cream and Bland cream (non-drug) in people with Skin Tear and Solar Purpura, run by James Thomas Pathoulas 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 5 inclusion and 11 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 28 May 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in frequency of skin tears. (time frame: 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084116, which also lists 1 linked publication.
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 28 May 2026.