Evaluation of Tretinoin Cream on the Integrity of Aged Forearm Skin

NCT ID: NCT07084116

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2026-02-01

Brief 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.

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.

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.

Conditions

Skin Tear; Solar Purpura; Dermatoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm participants apply tretinoin (LEFT or RIGHT)

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

Group Type: ACTIVE_COMPARATOR

Tretinoin 0.1% cream

Intervention Type: DRUG

Tretinoin 0.1% cream formulation.

Bland cream (non-drug)

Intervention Type: DRUG

Bland cream formulation.

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

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

Group Type: PLACEBO_COMPARATOR

Bland cream (non-drug)

Intervention Type: DRUG

Bland cream formulation.

Interventions

Tretinoin 0.1% cream

Tretinoin 0.1% cream formulation.

Intervention Type: DRUG

Bland cream (non-drug)

Bland cream formulation.

Intervention Type: DRUG

Other Intervention Names

Bland cream (non-medicated)

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kristin M. Nord

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Palo Alto VA Medical Center

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35620028 (View on PubMed)

Other Identifiers

77594

Identifier Type: -

Identifier Source: org_study_id