What is the mechanism of action of this treatment?

The most common treatments for Pilaris Keratosis often include high potency steroid-retinoid combinations, such as those found in Duobrii. Steroids work by reducing inflammation and suppressing the immune response, which helps to decrease the redness and swelling associated with the condition. Retinoids, on the other hand, promote cell turnover and prevent the plugging of hair follicles, which is a key factor in the development of Pilaris Keratosis. This combination is particularly effective because it addresses both the inflammatory and keratotic aspects of the condition, leading to smoother skin and reduced symptoms for patients.

What side effects are associated with this type of intervention?

Common treatments for Pilaris Keratosis include topical exfoliants, moisturizers, and retinoids. Treatments similar to Duobrii, which combine high potency steroids and retinoids, can have side effects such as skin irritation, redness, peeling, and dryness. Long-term use of high potency steroids may also lead to skin thinning, stretch marks, and increased risk of infections. It is important to use these treatments under medical supervision to manage and mitigate potential side effects.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Pilaris Keratosis in the provided context. However, Duobrii, a high potency steroid-retinoid combination, is being studied for its efficacy in treating conditions like Acne Keloidalis Nuchae. Similar treatments for skin conditions often involve the use of topical corticosteroids and retinoids, which are commonly used to manage various dermatologic conditions due to their anti-inflammatory and skin-renewing properties.

What other types of research exist?

Promising novel alternatives to Duobrii for Pilaris Keratosis patients in 2024 include Clascoterone (Cortexolone 17-alpha propionate, CB-03-01) topical cream, which has shown safety and tolerability in acne vulgaris, and other emerging treatments like tildrakizumab and risankizumab, which have demonstrated efficacy in psoriasis and may offer benefits for Pilaris Keratosis.

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Topical Steroid-Retinoid Combination

Duobrii for Acne Keloidalis Nuchae

Phase 3

Waitlist Available

Led By Benjamin N Ungar

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Are on systemic steroids or other immunosuppressants

Are using topical steroids or topical medications on their scalp within 4 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 12

Awards & highlights

Pivotal Trial

Summary

This trial tests Duobrii cream on men of African descent with early-mild AKN. The cream reduces inflammation and helps the skin renew itself, aiming to improve the condition of their skin. Duobrii is a new treatment for moderate to severe plaque psoriasis in adults.

Who is the study for?

This trial is for men and women over 18 with early-mild AKN (less than 6.5 cm wide). Women must not be pregnant, breastfeeding, or planning to become pregnant and should use birth control. Participants need to be in good health and haven't used certain medications for AKN, hair loss, or other scalp conditions recently.

What is being tested?

Researchers are testing Duobrii's effectiveness on early-mild AKN compared to a placebo and Bryhali. Patients will have scheduled visits over a period of 12 weeks where their symptoms will be assessed through surveys, photos, and clinical evaluations.

What are the potential side effects?

Duobrii may cause skin irritation or reactions at the application site due to its steroid-retinoid components. Other potential side effects could include changes in skin coloration or texture.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking steroids or other drugs that weaken my immune system.

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I haven't used any topical steroids or medications on my scalp in the last 4 weeks.

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I have an autoimmune disease, thyroid disorder, or am sensitive to steroids.

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I have used Duobrii for scalp conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in lesion count classification

Secondary study objectives

Changes in Itch Rating Scale

Changes in Pain Rating Scale

Changes in degree of dyspigmentation

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DuobriiExperimental Treatment2 Interventions

Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.

Group II: PlaceboPlacebo Group1 Intervention

Placebo

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Pilaris Keratosis often include high potency steroid-retinoid combinations, such as those found in Duobrii. Steroids work by reducing inflammation and suppressing the immune response, which helps to decrease the redness and swelling associated with the condition. Retinoids, on the other hand, promote cell turnover and prevent the plugging of hair follicles, which is a key factor in the development of Pilaris Keratosis. This combination is particularly effective because it addresses both the inflammatory and keratotic aspects of the condition, leading to smoother skin and reduced symptoms for patients.

Topical tazarotene for the treatment of ectropion in ichthyosis.Concomitant treatment of psoriasis of the hands and feet with pulsed dye laser and topical calcipotriol, salicylic acid, or both: a prospective open study in 41 patients.