Retinol for Skin Aging

Overseen By Kenvue Global Clinical Operations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Must not be taking: Anti-diabetics

Disqualifiers: Skin conditions, Smoking, Tanning, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how retinol, a topical treatment, affects aging skin at the genetic level. Researchers aim to determine if retinol can alter gene activity in the skin, potentially leading to visible improvements. Participants will use either a special night cream containing retinol or just a cleanser and sunscreen. Ideal candidates have moderate sun damage on their face and no major skin conditions or allergies to skincare products. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding of skincare and potentially enhance skin appearance.

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

The trial protocol does not specify if you must stop taking your current medications, but if you're on a medication that could mask a negative reaction or influence study results, you may need to stop, as determined by the principal investigator.

What prior data suggests that this skin tape stripping methodology is safe?

Research has shown that using topical retinol on the skin is generally safe and effective in reducing signs of skin aging, such as fine lines and dark spots. Most people tolerate it well, though some may experience mild irritation, including redness or peeling.

Retinol is often gentler on the skin than tretinoin, another type of retinoid. The FDA has approved tretinoin for treating skin aging, indicating its safety. However, caution is advised when using it with other skin products, as this can sometimes cause irritation. Following the instructions carefully can help reduce any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard skincare treatments for aging, which often involve moisturizers or serums with limited active ingredients, the investigational night cream in this trial uses topical retinol, a potent derivative of vitamin A known for its ability to promote skin cell turnover and boost collagen production. This cream stands out because it combines retinol with an auxiliary cleanser and sunscreen, creating a comprehensive skincare regimen aimed at maximizing the efficacy of retinol while minimizing irritation. Researchers are excited because this approach may offer more noticeable improvements in skin texture and tone compared to conventional anti-aging products, potentially delivering results faster and more effectively.

What evidence suggests that this trial's treatments could be effective for skin aging?

Studies have shown that creams with retinoids, like retinol, effectively improve signs of skin aging. Retinol significantly reduces fine wrinkles, making the skin appear smoother. In this trial, participants in the intervention arm will receive an investigational night cream containing retinol, along with an auxiliary cleanser and sunscreen. Research has indicated that a 0.05% tretinoin cream, another type of retinoid, is safe and effective for long-term use on aging skin. Tretinoin also improves the appearance of sun damage, such as wrinkles and uneven skin tone. Overall, retinoids are well-known for their ability to refresh the skin and are a trusted choice in anti-aging treatments. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with signs of skin aging or acne who are interested in testing a topical retinol product. Participants should not be currently using any night cream.

Inclusion Criteria

Is able to read, write, speak, and understand English

Has clinically determined moderate photodamage (defined as a score of 4 - 6 on a 0- 9-point scale) on the face at Visit 1

I am generally healthy.

Exclusion Criteria

Is currently participating in any other clinical study or has participated in any product-use study within 30 days prior to the study visit

I do not have skin conditions that could affect the study.

I am not on medication that could affect the study results.

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants use assigned products at home for 10 weeks, with visits at Day 28 and Day 71

10 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Topical Retinol

Trial Overview The study aims to see if a non-invasive method called skin tape stripping can detect gene expression changes in aged or acne-affected skin after applying a retinol-based night cream.

How Is the Trial Designed?

Group I: Intervention Cell Experimental Treatment 1 Intervention

Investigational Night Cream plus auxiliary cleanser and sunscreen

Group II: No Intervention Active Control 1 Intervention

Auxiliary cleanser and sunscreen only

Who Is Running the Clinical Trial?

Johnson & Johnson Consumer Inc. (J&JCI)

Lead Sponsor

Trials

57

Recruited

5,700+

Published Research Related to This Trial

Topical retinol (0.4%) significantly improved fine wrinkles in elderly skin after 24 weeks of treatment, showing a marked difference compared to a vehicle control.

The treatment also enhanced skin health by increasing glycosaminoglycan and collagen production, which may help the skin retain moisture and resist injury, contributing to a healthier appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of naturally aged skin with vitamin A (retinol). Kafi, R., Kwak, HS., Schumacher, WE., et al.[2008]

In a 1-month study involving 12 women with moderate to severe skin aging, the R-G gel containing retinoic acid and glycolic acid significantly improved skin aging signs, with Glogau scores decreasing from 3.4 to 2.7 (P = .0001).

Participants experienced notable reductions in dark spots (40%) and wrinkles (12%) after 4 weeks of treatment, along with improvements in skin cell structure as observed through reflectance confocal microscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy and reflectance confocal microscopy monitoring in moderate-severe skin aging treated with a polyvinyl gel containing retinoic and glycolic acid: An assessor-blinded 1-month study proof-of-concept trial. Campione, E., Cosio, T., Lanna, C., et al.[2021]

Both retinol and retinoic acid treatments increased epidermal thickness and boosted collagen production in the skin after four weeks, indicating their effectiveness in enhancing skin structure.

After 12 weeks of retinol application, participants experienced a significant reduction in facial wrinkles, demonstrating its efficacy as an anti-aging treatment, although the effects were slightly less pronounced than those of retinoic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of the effects of retinol and retinoic acid on histological, molecular, and clinical properties of human skin. Kong, R., Cui, Y., Fisher, GJ., et al.[2022]

Topical retinoids like adapalene, tazarotene, and tretinoin are FDA-approved and generally safe, effectively treating various skin disorders while having a favorable safety profile compared to systemic retinoids.

Local side effects such as peeling, dryness, and burning are common, especially at the start of treatment, but can be managed with proper care like using moisturizers and avoiding sun exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the safety and efficacy of topical retinoids. Phillips, TJ.[2013]

In a 22-month trial involving 30 patients, topical tretinoin effectively sustained improvements in fine and coarse wrinkling and skin texture, even with reduced application frequency after the initial 4-month study.

The treatment led to a 71% reduction in discrete lentigines (age spots) and resulted in significant thickening of the epidermis, with minimal side effects that decreased over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained improvement with prolonged topical tretinoin (retinoic acid) for photoaged skin. Ellis, CN., Weiss, JS., Hamilton, TA., et al.[2019]

In a study involving 40 female participants, both 0.1% and 0.05% retinaldehyde creams significantly improved skin hydration and texture after 3 months of use, demonstrating their efficacy in treating photoaged skin.

The 0.1% retinaldehyde cream was particularly effective, showing a significant improvement in the melanin index, while both formulations were well tolerated with minimal irritation compared to traditional retinoic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of retinaldehyde 0.1% and 0.05% creams used to treat photoaged skin: A randomized double-blind controlled trial. Kwon, HS., Lee, JH., Kim, GM., et al.[2018]

Tectorigenin is identified as a novel RAR-γ-selective agonist that effectively inhibits UV-induced skin damage, including oxidative stress and inflammation, while also reversing collagen loss, making it a promising treatment for photoaging.

In animal studies, tectorigenin demonstrated superior anti-inflammatory and anti-photoaging effects compared to all-trans retinoic acid (ATRA), with reduced skin irritation, suggesting it may be a safer alternative for treating UV-induced skin issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-retinol retinoic acid receptor-γ (RAR-γ/NR1B3) selective agonist, tectorigenin, can effectively inhibit the ultraviolet A-induced skin damage. Dai, X., Jin, J., Jia, Y., et al.[2022]

Tretinoin is the only medication proven to partially reverse signs of photoaging, with significant improvements observed clinically and histologically within 6 to 12 months of treatment.

For optimal results, tretinoin should be used alongside daily moisturizers and sunscreen, and further research is needed to explore its effects on different skin types and the psychosocial benefits of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoaging and the skin. The effects of tretinoin. Green, LJ., McCormick, A., Weinstein, GD.[2013]

Topical tretinoin (0.1% cream) has been shown to significantly improve the appearance of aging skin, with the most notable results observed after 8 to 12 months of use in both clinical trials and patient treatments.

The side effects of tretinoin are generally mild and temporary, including a slight burning sensation in the eyes and minor skin irritation, indicating a favorable safety profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical tretinoin in the treatment of aging skin. Weiss, JS., Ellis, CN., Headington, JT., et al.[2019]

A clinical study involving 34 women compared a tri-retinol 1.1% gradual release cream to tretinoin 0.025% cream for treating mild-to-moderate facial photodamage over three months, showing both products significantly improved signs of skin aging without significant differences in efficacy.

Both treatments were well-tolerated, with mild adverse effects typical of retinoids, and over 93% of participants reported satisfaction with the results after 8 and 12 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, controlled comparative trial of the anti-aging properties of non-prescription tri-retinol 1.1% vs. prescription tretinoin 0.025%. Ho, ET., Trookman, NS., Sperber, BR., et al.[2013]

Topical retinoids, especially tretinoin, isotretinoin, and tazarotene, are the only medical therapies proven to improve the appearance of photoaged skin, according to a randomized clinical trial.

Retinoids not only help repair photoaged skin but may also prevent further photoaging and show promise in treating intrinsically aged skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cosmeceuticals: focus on topical retinoids in photoaging. Serri, R., Iorizzo, M.[2008]

Topical tretinoin, a metabolite of vitamin A, has been shown to effectively treat various skin conditions, including ichthyosis, actinic keratoses, and acne vulgaris, by altering the keratinization process and promoting the shedding of dead skin cells.

The development of 13-cis-retinoic acid led to significant advancements in acne treatment, often resulting in permanent clearing of severe cases, and tretinoin has also demonstrated antitumor effects, particularly in basal cell cancers, highlighting its potential in cancer chemoprevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Historical perspectives of tretinoin. Stüttgen, G.[2019]

A study involving 20 participants found that topical alitretinoin gel 0.1% is well tolerated and shows subjective improvement in benign and precancerous skin lesions associated with photoaging.

Alitretinoin's unique ability to activate both retinoic acid receptors (RARs) and retinoid X receptors (RXRs) may enhance its effectiveness in promoting skin repair compared to other retinoids that only target RARs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label pilot study of alitretinoin gel 0.1% in the treatment of photoaging. Baumann, L., Vujevich, J., Halem, M., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9618501/

Use of Retinoids in Topical Antiaging Treatments The study results suggest that long-term use of 0.05% tretinoin emollient cream with a once-daily application is a safe and effective treatment. Although the ...

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

Comparative efficacy of topical interventions for facial ... Bayesian network meta-analysis showed isotretinoin, retinol, and tretinoin significantly improved fine wrinkles, with isotretinoin ranked ...

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

Topical tretinoin for treating photoaging: A systematic review ... Topical tretinoin was efficacious in improving clinical appearance of photoaging in terms of wrinkling, mottled hyperpigmentation, sallowness, and lentigines.

4. academic.oup.com academic.oup.com/bjd/article/189/Supplement_1/i17/7333865

Skin ageing and topical rejuvenation strategies This article reviews the clinical manifestations of skin ageing and the available topical treatments for skin rejuvenation, including retinoids, peptides and ...

5. 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.

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

Tretinoin (topical route) - Side effects & dosage Avoid using any topical medicine on the same area within 1 hour before or after using tretinoin. Otherwise, tretinoin may not work properly or skin irritation ...

7. drugs.com drugs.com/tretinoin.html

Tretinoin: Uses, Dosage, Side Effects, Warnings Tretinoin is used to treat acne (pimples) and sun damage as an anti-aging to help reduce the appearance of fine wrinkles and dark spots.

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

Retinoids in the treatment of skin aging Moreover, the treatment was safe and well tolerated in most of the patients. Tretinoin cream 0.02% is now recognized by the FDA for the treatment of photoaging.