What side effects are associated with this type of intervention?

Common acne treatments such as Benzoyl Peroxide, Salicylic Acid, and Retinoids are effective but can cause side effects. Benzoyl Peroxide often leads to skin irritation, dryness, and peeling. Salicylic Acid may cause skin irritation, dryness, and a mild stinging or burning sensation. Retinoids, including tretinoin and adapalene, can result in skin irritation, redness, peeling, and increased sensitivity to sunlight. Combining these treatments can improve results but may also heighten the risk of skin irritation.

What prior FDA approvals exist?

The FDA has approved several treatments for acne that include Benzoyl Peroxide, Salicylic Acid, and Retinoids. Benzoyl Peroxide is often used in combination with antibiotics like clindamycin to enhance efficacy and reduce antibiotic resistance. Salicylic Acid is an alternative for patients who cannot tolerate retinoids, helping to exfoliate the skin and unclog pores. Retinoids, such as adapalene and tretinoin, are effective in normalizing follicular keratinization and reducing inflammation. These treatments have been validated through multiple clinical trials demonstrating their effectiveness in reducing both inflammatory and non-inflammatory acne lesions.

What other types of research exist?

Promising novel alternatives for acne treatment in 2024 include: 1) Light therapy masks combining 445nm and 630nm wavelengths, which have shown significant improvement in acne lesions. 2) Combination topical treatments such as clindamycin/tretinoin hydrogel and adapalene/benzoyl peroxide, which have demonstrated efficacy in clinical trials. 3) Oral isotretinoin for severe cases, which remains a highly effective option. These alternatives offer various mechanisms to reduce inflammation, unclog pores, and kill bacteria.

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Other

Facial Cleansing Routines for Acne

Phase 4

Waitlist Available

Led By Shuai Xu

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two over-the-counter acne treatments, Geologie and Proactiv, on people with mild to moderate acne. The goal is to see which product is more effective over a few months. These treatments work by reducing skin inflammation and bacteria to help clear up acne. Proactiv is a well-known over-the-counter acne treatment that has been widely used and studied for its effectiveness in reducing acne symptoms.

Who is the study for?

This trial is for adults over 18 with mild to moderate acne, who have no active skin infections or allergies to the products being tested. Pregnant women, prisoners, and vulnerable populations are excluded, as well as those with any chronic disease or dermatological disorder that could affect participation.

What is being tested?

The study compares two OTC acne treatments: Geologie Acne Regimen on one side of the face and Proactive Acne Regimen on the other side. Participants will use these daily for 12 weeks to see which one is more tolerable.

What are the potential side effects?

Potential side effects may include skin irritation, dryness, redness, peeling or allergic reactions related to ingredients in either Geologie or Proactive acne regimens.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

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

Treatment Details

Study Objectives

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

Primary study objectives

Change in IGA Score between Geologie and ProActiv daily treatment

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Acne TreatmentExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Geologie Acne Regimen - one side of face

2022

Completed Phase 4

~30

Proactive Acne Regimen - other side of face

2022

Completed Phase 4

~30

Do I qualify?Apply below to find out

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

Benzoyl Peroxide works by killing acne-causing bacteria (C. acnes) and reducing inflammation, which helps to prevent new acne lesions from forming. Salicylic Acid helps to unclog pores by exfoliating the skin and removing dead skin cells, which reduces the occurrence of blackheads and whiteheads. Retinoids, such as tretinoin and adapalene, promote cell turnover and prevent the clogging of hair follicles, which helps to reduce the formation of acne lesions and inflammation. These mechanisms are crucial for acne patients as they address the root causes of acne, including bacterial growth, clogged pores, and inflammation, leading to clearer skin and reduced acne severity.

Management of comedonal acne vulgaris with fixed-combination topical therapy.Topical antimicrobial treatment of acne vulgaris: an evidence-based review.Randomised controlled multiple treatment comparison to provide a cost-effectiveness rationale for the selection of antimicrobial therapy in acne.