OTC Cream for Atopic Dermatitis

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Good Molecules, LLC

Must not be taking: Biologics, Antibiotics, Steroids, Immunomodulators

Disqualifiers: Pregnancy, Skin infections, Surgery, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an over-the-counter cream to determine its effectiveness for people with atopic dermatitis, a condition that causes itchy and inflamed skin. Researchers aim to understand the cream's impact on skin health by examining skin hydration, barrier function, and the skin's natural bacterial balance. The trial includes two groups: one using the cream and another not using any product. Candidates for this trial include those diagnosed with atopic dermatitis, experiencing visible flare-ups, and maintaining a stable skincare routine without conflicting treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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

The trial requires you to avoid conflicting topical treatments during the study. If you've used certain medications like biological drugs for atopic dermatitis, antibiotics, steroids, or immunomodulators in the past 4 weeks, you may not be eligible. The protocol doesn't specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that over-the-counter moisturizers can greatly help people with atopic dermatitis by keeping their skin strong and healthy. Studies have found that using these moisturizers, usually twice a day, improves skin condition in both children and adults with this issue.

Specific safety data for this particular cream is not available, but the trial is in Phase 3. By this stage, treatments have generally undergone safety testing in earlier phases. Serious side effects are unlikely, though minor ones like skin irritation might still occur. Discussing any concerns with a healthcare provider before joining the trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The over-the-counter (OTC) cream for atopic dermatitis is unique because it offers a potentially more accessible and convenient option for managing this skin condition. Unlike many existing treatments that often involve prescription-strength topical steroids or immunomodulators, this OTC product may provide effective relief without the need for a prescription, making it easier for patients to obtain. Researchers are excited about the possibility of this cream reducing inflammation and itching with fewer side effects, potentially making it a safer, more user-friendly alternative to current therapies.

What evidence suggests that this OTC cream might be an effective treatment for atopic dermatitis?

Research has shown that some over-the-counter (OTC) creams can greatly alleviate symptoms of atopic dermatitis, a type of eczema. One study found that 70.4% of children and 62% of adults using an OTC cream experienced reduced itch and pain by day 56. Additionally, skin quality improved by 75% in adults and 61% in children. Another study demonstrated that nonprescription moisturizers can significantly strengthen the skin barrier in both adults and children with atopic dermatitis. This trial will evaluate an OTC cream for atopic dermatitis, and these findings suggest that such creams can effectively manage and relieve symptoms. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with atopic dermatitis, a type of eczema. Participants will help researchers understand how an over-the-counter cream affects their skin condition and its microbiome.

Inclusion Criteria

I have not changed my skincare routine in the last 4 weeks.

I have dry or itchy skin patches on my forearms that can be evaluated.

Subject being used to applying topical treatments for atopic dermatitis

Exclusion Criteria

I haven't taken antibiotics, steroids, or immune system drugs in the last 4 weeks.

I need urgent treatment for a severe skin condition.

Pregnant or nursing woman or woman planning to get pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational OTC drug for atopic dermatitis and undergo skin microbiome analysis, skin hydration and barrier function measurement, and clinical improvement assessment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of arm redness, itching, and skin dryness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OTC Drug for Atopic Dermatitis

Trial Overview The study tests an unapproved OTC drug in cream form to see if it improves atopic dermatitis by analyzing changes in the skin's microbiome, hydration, and barrier function.

How Is the Trial Designed?

Group I: Atopic Dermatitis OTC Product Experimental Treatment 1 Intervention

Group II: No Product Active Control 1 Intervention

Who Is Running the Clinical Trial?

Good Molecules, LLC

Lead Sponsor

Sequential Skin Inc.

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7473959/

Efficacy of Nonprescription Moisturizers for Atopic Dermatitis Clinical studies showed that moisturization (typically twice daily) significantly improved the skin barrier in adults and children with AD.

2. jddonline.com jddonline.com/articles/individual-article-efficacy-of-over-counter-cream-in-reducing-eczema-signs-S1545961623S8641X/

Efficacy of Over-The-Counter Cream in Reducing Eczema ... At day 56, itch and pain improved in 70.4% of children and 62% of adults. DLQI scores were decreased by 75% in adults and 61% in children by day 56. Global skin ...

3. thelancet.com thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00146-8/fulltext

Effectiveness and safety of lotion, cream, gel, and ointment ... There was no difference in eczema symptoms between lotions, creams, gels, or ointments over 16 weeks. This finding was robust to sensitivity ...

4. jacionline.org jacionline.org/article/S0091-6749(23)01113-2/fulltext

Topical treatments for atopic dermatitis (eczema) With high-certainty evidence, pimecrolimus improved 6 of 7 outcomes—among the best for 2; high-dose tacrolimus (0.1%) improved 5—among the best ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4318661/

Efficacy and Tolerability of Steroid-Free, Over-the-Counter ... Results. Body Cream significantly improved skin hydration and reduced itching, burning/stinging, erythema, and tactile roughness. Instant Therapy significantly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10549798/

The long‐term safety of topical corticosteroids in atopic ... This review provides some reassuring data on growth and skin thinning when TCS are used intermittently for up to 5 years, but many knowledge gaps remain.

7. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15751

Safety of topical medications in the management of paediatric ... Data discussed here support the use of steroid-sparing medications (tacrolimus, pimecrolimus, crisaborole, delgocitinib) as safe options with minimal adverse ...