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

60 Participants Needed

Trial Summary

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 data supports the idea that Retinol for Skin Aging is an effective treatment?

The available research shows that Retinol, specifically in the form of tretinoin, is effective in treating skin aging. Studies have demonstrated that tretinoin can improve the appearance of aged skin, with significant improvements in fine and coarse wrinkles, skin texture, and a reduction in age spots after 8 to 12 months of use. One study found a 71% decrease in age spots. Another study compared prescription tretinoin with a non-prescription retinol product and found both significantly improved signs of skin aging, with no major differences in effectiveness. Overall, tretinoin is the only treatment with proven benefits for reversing signs of photoaging, according to the research. ^{1 2 3 4 5}

What safety data exists for retinol treatments for skin aging?

Topical retinoids like tretinoin have favorable safety profiles and are effective for various skin disorders, including aging. Common local side effects include peeling, erythema, dryness, burning, and itching, which can be minimized with precautions like using moisturizers and avoiding sunlight. Tretinoin has been shown to improve aged skin with mild, transient side effects. Alitretinoin gel was well tolerated in a small study, showing potential for treating photoaging. Overall, topical retinoids are considered safer than systemic retinoids. ^{1 6 7 8 9}

Is retinol a promising treatment for skin aging?

Yes, retinol is a promising treatment for skin aging. It is effective in improving the appearance of aged skin and is widely used in skincare products. Retinol is a form of vitamin A and works by promoting skin renewal, which can help reduce signs of aging. ^{1 10 11 12 13}

What is the purpose of this trial?

This study is being conducted to confirm whether skin tape stripping methodology can identify changes in gene expression (i.e. whether different genes are turned on to make proteins) in aged skin after use of a retinoid.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical tretinoin in the treatment of aging skin. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Sustained improvement with prolonged topical tretinoin (retinoic acid) for photoaged skin. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Photoaging and the skin. The effects of tretinoin. [2013]

4. United States 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%. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Cosmeceuticals: focus on topical retinoids in photoaging. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Historical perspectives of tretinoin. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Open-label pilot study of alitretinoin gel 0.1% in the treatment of photoaging. [2018]

10. England 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. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Improvement of naturally aged skin with vitamin A (retinol). [2008]

12. England 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. [2021]

13. England 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. [2022]