Evaluation of Tretinoin Cream on the Integrity of Aged Forearm Skin

NCT07084116 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: 77594
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Tear; Solar Purpura; Dermatoporosis

Keywords

skin tear; thin skin

Outcome Measures

Primary Outcomes (2)

• Change in frequency of skin tears.

  6 months.

• Change in epidermal (top layer of skin) thickness.

  6 months.

Secondary Outcomes (1)

• Change in percent of skin on the arms involved by solar purpura (bruising).

  6 months.

Study Arms (2)

Arm participants apply tretinoin (LEFT or RIGHT)

ACTIVE COMPARATOR

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

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.

Drug: Bland cream (non-drug)

Interventions

Tretinoin 0.1% cream DRUG

Tretinoin 0.1% cream formulation.

Also known as: Bland cream (non-medicated)

Arm participants apply tretinoin (LEFT or RIGHT)

Bland cream (non-drug) DRUG

Bland cream formulation.

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Palo Alto VA Medical Center

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 35620028 BACKGROUND

MeSH Terms

Interventions

Tretinoin

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: July 14, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)