Facial Creams for Photoaging

Age: 18 - 65

Sex: Female

Trial Phase: Academic

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

Must not be taking: Anti-diabetics

Disqualifiers: Severe acne, Psoriasis, Rosacea, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking a medication that could affect the study results, you may not be eligible to participate.

What data supports the effectiveness of the drug Facial Cream A or Facial Cream B for photoaging?

Research shows that topical retinoids, like isotretinoin, improve the appearance of photodamaged skin by reducing wrinkles and improving skin texture. Additionally, a combination of retinol, lactose, and glycolic acid has been shown to significantly improve photodamaged skin, suggesting that similar ingredients in facial creams could be effective. ^{1 2 3 4 5}

Is there any safety data available for facial creams used in clinical trials?

There is safety data available from studies on skin care products and procedures, which monitor adverse events (unwanted effects) and skin reactions. These studies help ensure that products are safe for use on human skin, including those with sensitive skin. ^{6 7 8 9 10}

How does Facial Cream A and Facial Cream B differ from other treatments for photoaging?

Facial Cream A and Facial Cream B may offer a unique approach to treating photoaging by potentially incorporating ingredients like isotretinoin, which is known for its anti-acne properties but also has anti-aging potential, although it can be irritating to the skin. This differs from other treatments like tazarotene and tretinoin creams, which are retinoids specifically studied for their effectiveness in reducing signs of photoaging. ^{11 12 13 14 15}

What is the purpose of this trial?

The objective of this study is to evaluate the efficacy of a retinol alternative-containing facial cream in improving skin texture, radiance/brightness, and the appearance of fine lines, wrinkles, uneven skin tone, and dark spots, with a positive control of a retinol-containing cream.

Eligibility Criteria

This trial is for individuals with moderate to severe photodamaged skin, who are generally healthy and have Fitzpatrick Skin Type I-IV. Participants must understand English, agree to photo consent, and follow study instructions. Excluded are those with allergies to skincare ingredients, very sensitive skin, diabetes, certain health risks or conditions that could affect results, pregnant or lactating women, and anyone in another study within the last 30 days.

Inclusion Criteria

I am generally healthy.

Fitzpatrick Skin Type I, II, III, or IV

Able to read, write, speak, and understand English

Exclusion Criteria

Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study materials

Has self-perceived very sensitive skin

I have diabetes or am taking medication for it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either Facial Cream A or Facial Cream B for 12 weeks to evaluate efficacy on photodamaged skin

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Facial Cream A
• Facial Cream B

Trial Overview The trial compares two facial creams: one contains a retinol alternative and the other contains retinol. The goal is to see which cream better improves skin texture, radiance/brightness, fine lines/wrinkles, uneven tone and dark spots. Participants will be assessed by a principal investigator for their level of photodamage.

Participant Groups

Group I: Arm 2: Facial Cream B (Cell B) Experimental Treatment 1 Intervention

Each subject will be provided with the assigned IP (Facial Cream B) and the APs to use for 12 weeks.

Group II: Arm 1: Facial Cream A (Cell A) Experimental Treatment 1 Intervention

Each subject will be provided with the assigned IP (Facial Cream A) and the APs to use for 12 weeks.

Who Is Running the Clinical Trial?

Johnson & Johnson Consumer Inc. (J&JCI)

Lead Sponsor

Trials

57

Recruited

5,700+

Findings from Research

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]

Before using a new topical product on diseased skin, it is crucial to first assess its safety on healthy skin in human volunteers.

The paper outlines guidelines for evaluating potential skin irritation, sensitization, phototoxicity, and photoallergy of topical products, emphasizing the need for a structured safety evaluation approach since current studies lack regulatory oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical trials in dermatology. The phase I trials]. Czernielewski, J., Queille-Roussel, C., Duteil, L., et al.[2013]

The CAPER Registry is a national safety reporting program that collects data on adverse events from dermatologic procedures, aiming to enhance safety monitoring in the field.

By identifying gaps in resources, processes, and education related to adverse events, CAPER seeks to improve clinical practices and prevent future incidents, benefiting practitioners, patients, and regulatory bodies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cutaneous Procedures Adverse Events Reporting (CAPER) Registry. Kang, BY., Ibrahim, SA., Poon, E., et al.[2022]

In a 48-week study involving 40 patients, tretinoin emollient cream 0.01% significantly improved skin conditions such as fine and coarse wrinkling on the face and roughness and hyperpigmentation on the forearms, with notable results at 24 weeks (P < .001).

The treatment was generally well tolerated, with minimal skin irritation reported, although some patients experienced dryness and peeling; dermatitis was the most common adverse event on the forearms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tretinoin emollient cream 0.01% for the treatment of photoaged skin. Andreano, JM., Bergfeld, WF., Medendorp, SV.[2019]

References

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

Topical isotretinoin for photodamaged skin. [2019]

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

Treatment of lateral canthal rhytides with a medium depth chemical peel with or without pretreatment with onabotulinum toxin type A: a randomized control trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Topical treatments for photoaged skin. Separating the reality from the hype. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Combined retinol-lactose-glycolic acid effects on photoaged skin: a double-blind placebo-controlled study. [2016]

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

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

6. New Zealand pubmed.ncbi.nlm.nih.gov

Skin acceptability of a cosmetic moisturizer formulation in female subjects with sensitive skin. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Clinical trials in dermatology. The phase I trials]. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

The Cutaneous Procedures Adverse Events Reporting (CAPER) Registry. [2022]

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

Adverse Event Incidences following Facial Plastic Surgery Procedures: Incorporating FACE-Q Data to Improve Patient Preparation. [2021]

10. England pubmed.ncbi.nlm.nih.gov

An open-label trial examining the efficacy and safety of a pre- and postprocedure topical five-product system (Clinique Medical Optimizing Regimen) specifically formulated to complement laser/light-based facial cosmetic procedures. [2014]

11. England pubmed.ncbi.nlm.nih.gov

Nano-lipoidal carriers of isotretinoin with anti-aging potential: formulation, characterization and biochemical evaluation. [2013]

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

Tazarotene cream for the treatment of facial photodamage: a multicenter, investigator-masked, randomized, vehicle-controlled, parallel comparison of 0.01%, 0.025%, 0.05%, and 0.1% tazarotene creams with 0.05% tretinoin emollient cream applied once daily for 24 weeks. [2019]

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

Tretinoin emollient cream 0.01% for the treatment of photoaged skin. [2019]

14. Canada pubmed.ncbi.nlm.nih.gov

Tazarotene 0.1% cream for the treatment of photodamage. [2014]

15. England pubmed.ncbi.nlm.nih.gov

The impact of topical photoprotectants intended for daily use on lifetime ultraviolet exposure. [2011]