Tretinoin Cream for Aged Skin

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Stanford University

Must not be taking: Oral steroids, Isotretinoin

Disqualifiers: Pregnancy, Atopic dermatitis, Chemotherapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tretinoin cream can reduce skin tears and bruising and increase skin thickness. Participants will apply tretinoin cream on one arm and a placebo cream on the other for six months. It targets adults over 55 who frequently experience skin tears and bruising. The goal is to determine if tretinoin cream improves skin condition compared to the placebo. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using any topical medications on your forearms and oral steroids for at least a month before starting. If you have used isotretinoin, you must wait six months before participating.

Is there any evidence suggesting that tretinoin cream is likely to be safe for humans?

Research shows that tretinoin cream is usually safe for skin use. Studies have found that common side effects include mild itching and skin irritation. These occur because tretinoin accelerates skin cell renewal, sometimes causing temporary discomfort.

Clinical studies have safely used tretinoin to treat skin issues like acne. Serious side effects are rare but can include trouble breathing or a fast heartbeat. Most people experience only mild reactions. The FDA has also approved tretinoin for treating other skin conditions, indicating its general safety.

Participants should be aware of these possible effects and discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tretinoin cream is unique because it directly targets the aging process of the skin by promoting cell turnover and stimulating collagen production. Unlike standard moisturizers or topical treatments that primarily focus on hydration and surface-level improvements, tretinoin works at a deeper level to rejuvenate skin structure and appearance. Researchers are excited about tretinoin's potential to provide more significant and lasting improvements in skin texture and elasticity compared to existing options.

What evidence suggests that tretinoin cream might be an effective treatment for aged skin?

Research shows that tretinoin cream can improve signs of skin aging. In this trial, participants will apply tretinoin 0.1% cream nightly to one arm for six months, while a bland cream serves as a placebo on the other arm. Studies have found that tretinoin significantly enhances the appearance of sun-damaged skin, reducing wrinkles and other aging signs. Over approximately six months, tretinoin has demonstrated major improvements. The cream accelerates skin renewal, which may also strengthen the skin to reduce tears and bruising. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 55 who can apply cream themselves and have a history of skin tears or bruising on their forearms. It's not for those pregnant, breastfeeding, allergic to tretinoin, with certain skin diseases, using steroids or topical meds recently, or undergoing specific therapies.

Inclusion Criteria

I have had at least 2 skin tears in the last month.

I have a history of easy bruising on my skin from sun exposure.

I am 55 years old or older.

Exclusion Criteria

Pregnant or breastfeeding

History of allergy to tretinoin

I plan to have skin surgery on my forearm soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply tretinoin 0.1% cream nightly to one forearm and a bland cream to the other forearm for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tretinoin Cream

Trial Overview The study tests if applying tretinoin cream (a vitamin A derivative) every night reduces forearm skin tears and bruising compared to a bland cream without active ingredients. The effects on skin thickness will also be observed over six months.

How Is the Trial Designed?

Group I: Arm participants apply tretinoin (LEFT or RIGHT) Active Control 2 Interventions

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

Group II: Arm participants apply bland cream (not treatment) (LEFT or RIGHT) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9112391/

Topical tretinoin for treating photoaging: A systematic review ... With regard to efficacy, all studies consistently reported that topical tretinoin was efficacious in improving clinical appearance of photoaging in terms of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2699641/

Retinoids in the treatment of skin aging Tretinoin treatment showed significant improvement in the clinical signs of photoaging. However, the major degree of changes occurred after 6 months and later ...

3. nature.com nature.com/articles/s41598-025-12597-0

Comparative efficacy of topical interventions for facial ... Tretinoin showed significant efficacy with an OR of 6.87 (95% CI [2.88, 16.37], P < 0.0001). According to the results, isotretinoin, retinol and ...

4. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2792866

Biomarkers of Tretinoin Precursors and Tretinoin Efficacy in ... In this randomized clinical trial of 24 patients, at week 24, there was no significant difference in photoaging scores among those treated with TTP vs RA.

5. dpcj.org dpcj.org/index.php/dpc/article/view/5172

Tretinoin for Photodamaged Facial Skin Conclusion: Topical tretinoin is a safe and effective treatment for fine and coarse facial wrinkles resulting from photodamage. References.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf

RENOVA (TRETINOIN CREAM) 0.02% FOR TOPICAL USE ... Safety and effectiveness in patients less than 18 years of age have not been established. Geriatric Use. In clinical studies with RENOVA. ®. (tretinoin cream) ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/tretinoin-topical-route/description/drg-20066521

Tretinoin (topical route) - Side effects & dosage Description. Tretinoin is used to treat acne vulgaris or other skin diseases as determined by your doctor. It works partly by keeping skin pores clear.

8. goodrx.com goodrx.com/renova/what-is?srsltid=AfmBOorp7gB8s0G99iorL8ZQm8kCGJoP4WoTL6brr38Ic9KHdpuths7a

Renova (Tretinoin): Uses, Side Effects, Tips & More People who used Renova (tretinoin) in clinical studies didn't report skin purging as a side effect. Skin purging is a reaction typically seen when retinoids, ...

9. webmd.com webmd.com/drugs/2/drug-3956/tretinoin-topical/details

Tretinoin topical (Retin-A, Renova, and others) - Uses, Side ... What are the serious side effects of topical tretinoin? · Breathing problems or wheezing · Racing heart · Fever or general ill feeling · Swollen ...

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557478/

Tretinoin - StatPearls - NCBI Bookshelf - NIH According to the FDA drug labeled guidelines, the most common adverse effects in topically administered tretinoin are the following: pruritus, skin pain, skin/ ...