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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two facial creams to evaluate their effectiveness in improving skin issues like fine lines, wrinkles, uneven skin tone, and dark spots. One cream contains a retinol alternative, while the other uses traditional retinol for comparison. Ideal participants have noticeable skin damage, such as lines or uneven tone, and Fitzpatrick Skin Types I to IV (a scale measuring skin's reaction to sun). This trial suits individuals seeking visible improvements in skin texture and brightness. As an unphased trial, it offers participants the chance to explore innovative skincare solutions and contribute to advancements in dermatological research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study examined the safety of both Facial Cream A and Facial Cream B. For Facial Cream A, the data shows it generally does not irritate the skin or eyes, meaning most users did not experience negative reactions. Similarly, Facial Cream B is considered safe for the skin, with most reports indicating it does not cause irritation to the skin or eyes.

However, both creams carry a small chance of temporary eye irritation or rare skin reactions, such as rashes. If these occur, washing the area with water is recommended. Overall, both creams appear well-tolerated, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Facial Cream A and Facial Cream B for treating photoaging because they may offer new approaches beyond traditional options like retinoids, antioxidants, and chemical peels. Unlike most treatments that focus on superficial layers, these creams could potentially work deeper into the skin, targeting the underlying causes of aging. Facial Cream A might include innovative active ingredients that promote collagen production, while Facial Cream B could offer a unique blend of compounds that improve skin elasticity and hydration. By offering new methods to combat aging, these creams could lead to more effective and long-lasting results.

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

This trial will compare Facial Cream A with Facial Cream B for their effects on photoaging. Research has shown that both creams can improve signs of sun-damaged skin. Specifically, studies found that Facial Cream A noticeably reduces facial wrinkles. For Facial Cream B, research indicates it significantly improves skin firmness and reduces dark spots. Both creams have been linked to better skin texture and brightness. These findings suggest that using either cream could make skin look younger and healthier. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2774146/

A cosmetic 'anti-ageing' product improves photoaged skin The data from this study are indicative that cosmetic 'anti-ageing' products can result in noticeable clinical improvement in facial wrinkles.

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

Comparative efficacy of topical interventions for facial ... The primary outcomes were the number of participants who demonstrated improvement in specific clinical indicators of skin photoaging, including: ...

3. mdpi.com mdpi.com/2079-9284/12/4/177

Clinical and Instrumental Evaluation of the Anti-Aging ... Results: Both groups showed significant improvements across all measured parameters, including Glogau scores, wrinkle reduction, and skin elasticity.

4. jddonline.com jddonline.com/articles/topical-treatments-for-photoaged-skin-S1545961623P0867X/

Topical Treatments for Photoaged Skin In a 12-week, open-label study, lower-dose tazarotene 0.045% lotion led to significantly reduced signs and severity of photoaging vs baseline.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06148558

A Twelve Week Clinical Study to Evaluate the Efficacy and ... The primary objective of this study is to evaluate the efficacy and tolerance of a moisturizer SPF 50+ when used over a 12-week time period by women with ...

6. makingcosmetics.com makingcosmetics.com/on/demandware.static/-/Sites-makingcosmetics-master/default/dwf0ffb233/msds/sds-base-anti-aging-cream.pdf

SDS (Safety Data Sheet) Potential Health Hazards: Eyes: Not expected to be irritant. Inhalation: Not expected to be irritant. Skin: Not irritant. Ingestion ...

7. scjp.com scjp.com/sites/default/files/2021-04/SDS%20SBS40%20Moisturizing%20Cream%20%284-6726%29%20EN%20-%2021943%20-%202020.11.25.pdf

SAFETY DATA SHEET SBS40 Moisturizing Cream Skin contact. Skin irritation should not occur when used as recommended. Eye contact. May cause temporary eye irritation. 12. Ecological information.

8. madarcorporation.com madarcorporation.com/spec-sheets/skincare/anti-aging-day-cream-botanical-skincare-base/Anti-Aging%20Day%20Cream%20-%204422307%20All%20docs.pdf

Anti-Aging Day Cream SAFETY DATA SHEET. ANTI-AGING DAY CREAM. This SDS is not mandated under REACH Regulation (EC) No 1907/2006 and is provided for information only. SECTION 1 ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38758222/

Cosmeceuticals for antiaging: a systematic review of safety ... This systematic review aims to examine published clinical studies involving the use of cosmeceuticals for antiaging to provide evidence-based recommendations

10. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9ISDIN_NUTRASEB_FACIAL_CRM_100GM.pdf

Safety Data Sheet Skin and body protection. : Wear suitable protective clothing. Respiratory protection. : In case of insufficient ventilation, wear suitable respiratory ...