A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity

Overseen By Jacob Tower, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adipeau Inc.

Disqualifiers: Facial resurfacing, Injectable fillers, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a natural face cream on healthy volunteers to see if it can make their skin stronger and more elastic by helping the skin produce new cells and get rid of old ones.

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

The trial information does not specify whether you need to stop taking your current medications.

Is the Adipeau face cream generally safe for use in humans?

Cosmetic products, including face creams, can sometimes cause skin reactions like allergic contact dermatitis (skin inflammation due to an allergy) or irritant contact dermatitis (skin irritation from a substance). While these reactions are not uncommon, they are usually mild and affect the skin where the product is applied. ^{1 2 3 4 5}

Who Is on the Research Team?

Jacob Tower, MD

Principal Investigator

Romo Plastic Surgery

Are You a Good Fit for This Trial?

Inclusion Criteria

-

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply the Adipeau face cream to improve skin elasticity and volume

12 months

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adipeau face cream

How Is the Trial Designed?

Group I: Adipeau face cream Experimental Treatment 1 Intervention

Cosmetic cream

Who Is Running the Clinical Trial?

Adipeau Inc.

Lead Sponsor

Trials

1

Recruited

80+

Romo Plastic Surgery

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

A pilot project to collect reports of undesirable effects (UEs) from cosmetic products revealed that dermatologists were the primary reporters, submitting 47 out of 76 total reports, highlighting the need for better reporting systems in cosmetovigilance.

The majority of reported UEs were cutaneous reactions, with allergic contact dermatitis and irritant contact dermatitis being the most common diagnoses, indicating that facial and body care products are significant contributors to these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notification of undesirable effects of cosmetics and toiletries. Sportiello, L., Cammarota, S., de Portu, S., et al.[2015]

Between 2004 and 2017, 41% of all adverse events related to cosmetics reported to the FDA were cancer-related, totaling 4427 reports, with a significant number linked to ovarian cancer and talc powders.

The current data from the FDA's adverse event reporting system is limited due to high rates of redaction and potential reporter bias, indicating a need for improved reporting practices and regulatory science to better assess the safety of cosmetic products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration. Jacob, SL., Cornell, E., Kwa, M., et al.[2023]

Citations

1. Sweden pubmed.ncbi.nlm.nih.gov

Are adverse skin reactions to cosmetics underestimated in the clinical assessment of contact dermatitis? A prospective study among 1075 patients attending Swedish patch test clinics. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Excipients in topical corticosteroid preparations in Canada. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Notification of undesirable effects of cosmetics and toiletries. [2015]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration. [2023]