Evaluation of Tretinoin Cream on the Integrity of Aged Forearm Skin

Stanford University

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Skin Tear; Solar Purpura; Dermatoporosis

Treatments: Drug: Bland cream (non-drug); Drug: Tretinoin 0.1% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07084116

77594

Details and patient eligibility

About

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.

Full 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.

This research study is 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• <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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Arm participants apply tretinoin (LEFT or RIGHT)

Active Comparator group

Description:

Participants will apply tretinoin 0.1% cream nightly for 6 months.

Treatment:

Drug: Tretinoin 0.1% cream

Drug: Bland cream (non-drug)

Arm participants apply bland cream (not treatment) (LEFT or RIGHT)

Placebo Comparator group

Description:

Participants apply bland cream to the other arm nightly as a placebo.

Treatment:

Drug: Bland cream (non-drug)