Topical Acne Medications for Acne

Overseen By Irma M Richardson, MHA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, No acne, others

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

Compensation: Varies

Number of Visits: 56

Duration: 8 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different topical gels to evaluate their effectiveness in treating acne. Researchers aim to determine whether using one, two, or three gels daily can enhance acne treatment and improve adherence to medication routines. The trial seeks adults in the US who have acne and understand English well. Participants will apply the gels daily as part of the study. As an Early Phase 1 trial, this study explores the initial effects of the gels on acne, offering participants the chance to contribute to groundbreaking research.

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

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

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

A previous study tested adapalene gel on people with acne and found similar side effects over a year. These side effects were not severe, with common ones including mild skin irritation such as redness or dryness. This suggests the gel is generally well-tolerated.

Research has shown that clindamycin phosphate and benzoyl peroxide gel treats acne effectively. Mild side effects like burning, itching, or dryness can occur but are usually not serious. The gel targets acne-causing bacteria and helps keep pores clear.

Both treatments have approval for acne, providing some confidence in their safety. However, as this trial is in the early stages, more research is needed to fully understand the safety and effects in different groups of people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for acne because they combine powerful ingredients in new ways. Unlike standard treatments that often use a single active ingredient, these investigational treatments explore combinations like adapalene with clindamycin phosphate and benzoyl peroxide. Adapalene is a retinoid that helps unclog pores, while clindamycin phosphate is an antibiotic, and benzoyl peroxide is known for killing bacteria and reducing inflammation. By using these in combination, there's potential for enhanced effectiveness in reducing acne and preventing future breakouts. This multi-pronged approach could offer more comprehensive acne management compared to traditional single-agent therapies.

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

Studies have shown that adapalene gel effectively reduces acne. A review of over 900 patients found adapalene 0.1% gel to be as effective as tretinoin, another common acne treatment. In this trial, some participants will use adapalene gel alone. Research on clindamycin phosphate combined with benzoyl peroxide gel indicates it significantly improves acne. This combination not only reduces acne but also enhances users' quality of life. In this trial, other participants will use the clindamycin phosphate/benzoyl peroxide gel, either alone or with adapalene. Both treatments have proven effective and safe for managing acne. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in the US with a current acne diagnosis who can communicate well in English. It's not for those without an acne diagnosis, under 18, non-US residents, or those who don't speak English sufficiently.

Inclusion Criteria

Patients have sufficient command of the English language

Patients who live in the US

I am currently diagnosed with acne.

Exclusion Criteria

I am not fluent in English.

I do not have a current diagnosis of acne.

Patients who do not live in the US

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply topical acne medications daily as per assigned treatment group

8 weeks

End of study visit on day 56

Follow-up

Participants are monitored for adherence and satisfaction with the treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapalene Gel
• Clindamycin Phosphate/Benzoyl Peroxide Gel

Trial Overview The study tests daily use of adapalene gel alone and combined with benzoyl peroxide/clindamycin phosphate gel to treat acne. The goal is to see which treatment works better and how patients stick with them.

How Is the Trial Designed?

Group I: Two gel treatment Experimental Treatment 1 Intervention

One-third of the participants will be instructed to apply adapalene and the clindamycin phosphate/benzoyl peroxide gel every day.

Group II: Three gel treatment Experimental Treatment 1 Intervention

One-third of the participants will be instructed to apply adapalene, benzoyl peroxide gel, and clindamycin phosphate gel every day.

Group III: One gel treatment Experimental Treatment 1 Intervention

Every participant will be instructed to apply a topical retinoid every day.

Adapalene Gel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Differin for:

• Acne vulgaris

Approved in European Union as Differin for:

• Acne vulgaris
• Seborrhoeic keratoses

Approved in Canada as Differin for:

• Acne vulgaris

Approved in Japan as Differin for:

• Acne vulgaris

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Bausch Health Americas, Inc.

Industry Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

Published Research Related to This Trial

In a study involving 498 patients with moderate to severe acne, the clindamycin phosphate 1.2% and benzoyl peroxide 3.75% gel significantly reduced both inflammatory and noninflammatory acne lesions compared to a placebo over 12 weeks.

The treatment was well tolerated, with over half of the severe acne patients showing a significant improvement in severity scores, and no patients discontinued due to adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of a Fixed Combination of Clindamycin Phosphate (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate and Severe Acne Vulgaris Subpopulations. Stein Gold, L.[2015]

In a 12-week study involving 498 patients aged 12-40, the clindamycin phosphate and benzoyl peroxide combination gel significantly reduced both inflammatory and noninflammatory acne lesions compared to a placebo.

The treatment was well-tolerated, with no patients discontinuing due to adverse effects, indicating a favorable safety profile alongside its efficacy in improving acne severity and skin oiliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 3.75% for the once-daily treatment of moderate to severe acne vulgaris. Pariser, DM., Rich, P., Cook-Bolden, FE., et al.[2014]

Topical fixed combination therapies, such as adapalene 0.3%-benzoyl peroxide (BP) 2.5%, have been shown to be effective in treating severe acne, while lower concentrations of adapalene did not provide significant benefits over a placebo.

Clindamycin-BP gels demonstrated effectiveness in severe acne, with a dose-response relationship indicating that higher BP concentrations may yield better results, suggesting that topical treatments can be a viable alternative to systemic antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Severe Acne Vulgaris With Topical Therapy. Stein Gold, L., Baldwin, HE., Lin, T.[2022]

In a study of 498 patients with moderate-to-severe acne over 12 weeks, clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel demonstrated a favorable safety profile, with 80-95% of patients reporting no cutaneous issues.

Moderate or severe reactions were rare, occurring in only a small percentage of patients, and were generally mild, indicating that the gel is well-tolerated for treating acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous Safety and Tolerability of a Fixed Combination Clindamycin (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate-to-severe Acne Vulgaris. Webster, G.[2020]

In a 12-week study involving 382 participants, the clindamycin 1%-benzoyl peroxide 5% gel with hydrating excipients (C/BPO HE) showed a higher treatment success rate (30.5%) compared to the adapalene 0.1%-benzoyl peroxide 25% gel (A/BPO) at 21.8%, indicating that C/BPO HE is more effective in improving acne severity.

C/BPO HE was better tolerated and safer than A/BPO, with fewer participants experiencing adverse effects (48.4% vs. 78.6%), making it a preferable option for acne treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Zouboulis, CC., Fischer, TC., Wohlrab, J., et al.[2015]

In a study of 69 Asian patients with mild to moderate acne, the combination gel of clindamycin phosphate 1% and benzoyl peroxide 5% (CDP/BPO) was found to be more effective than adapalene 0.1% (ADA) in reducing inflammatory acne lesions over a 12-week period.

Both CDP/BPO and ADA were well tolerated with minimal adverse reactions, indicating that they are safe options for treating acne in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, open-label, comparative study of clindamycin 1%/benzoyl peroxide 5% gel with adapalene 0.1% gel in Asian acne patients: efficacy and tolerability. Ko, HC., Song, M., Seo, SH., et al.[2015]

In a study involving 2813 patients with moderate to severe acne, the combination treatment of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) was found to be significantly more effective than using the individual ingredients or a placebo, showing improvements in acne severity as early as week 2.

The treatment was well-tolerated, with less than 1% of patients discontinuing due to adverse events, indicating a favorable safety profile for clindamycin-BPO 2.5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An aqueous gel fixed combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the once-daily treatment of moderate to severe acne vulgaris: assessment of efficacy and safety in 2813 patients. Thiboutot, D., Zaenglein, A., Weiss, J., et al.[2014]

In a study of 76 participants with mild-to-moderate acne, clindamycin/benzoyl peroxide gel was found to be better tolerated than adapalene/benzoyl peroxide gel, showing significantly lower scores for redness, dryness, and peeling during the first two weeks of treatment.

Both treatments improved acne severity, but clindamycin/benzoyl peroxide gel continued to show significant improvement in lesion counts and overall skin condition even after an additional six weeks of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Tolerability Profile of Clindamycin 1%/Benzoyl Peroxide 5% Gel vs. Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel for Facial Acne: Results of Two Randomized, Single-Blind, Split-Face Studies. Green, L., Cirigliano, M., Gwazdauskas, JA., et al.[2021]

In a study of 40 participants with moderate to severe facial acne, both clindamycin phosphate-benzoyl peroxide combinations (5% and 2.5%) with tazarotene cream were found to be effective and well-tolerated over 12 weeks of treatment.

The combination with 5% benzoyl peroxide caused more initial burning/stinging compared to the 2.5% formulation, but overall, both treatments showed similar tolerability and efficacy by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clindamycin phosphate 1.2%-benzoyl peroxide (5% or 2.5%) plus tazarotene cream 0.1% for the treatment of acne. Dhawan, SS., Gwazdauskas, J.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2374937/

A review of the use of adapalene for the treatment of acne ... A meta-analysis of five large studies with more than 900 patients over 12 weeks demonstrated that adapalene 0.1% gel is as effective as tretinoin 0.025% gel ( ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11843229/

Pivotal clinical trials of adapalene in the treatment of acne Adapalene cream 0.1% has proven to be significantly more effective than vehicle, with response rates comparable to those observed with the gel and solution. A ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962297700562

Clinical efficacy and safety comparison of adapalene gel ... Results: Adapalene gel 0.1% was significantly more effective in treating acne lesions than 0.03% adapalene gel. Adapalene gel 0.1% was significantly more ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07102186

Efficacy and Safety of Adapalene Gel and Hyaluronic Acid ... Key outcomes include acne lesion reduction, incidence and severity of side effects (erythema, dryness, scaling, stinging/burning, pruritus), and ...

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/405282

Adapalene Gel, 0.1%, as Maintenance Therapy for Acne ... Main Outcome Measures Efficacy and safety criteria included maintenance rate (subjects maintaining at least 50% improvement in lesion counts from previous ...

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9GALD_DIFFERIN_GEL_0_1_45GM.pdf

SAFETY DATA SHEET This is a personal care or cosmetic product that is safe for consumers and other users under the intended and reasonably foreseeable use.

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9ACTAS_ADAPALENE_GEL.pdf

SAFETY DATA SHEET The safety and efficacy of Adapalene Gel in pregnancy has not been established. ... Consult Safety Data Sheet for additional information.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf

Differin (adapalene) gel label - accessdata.fda.gov In a one-year, open-label safety study of 551 patients with acne who received DIFFERIN Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week.

9. vionausa.com vionausa.com/wp-content/uploads/2022/06/Adapalene-and-Benzoyl-Peroxide-Topical-Gel_SDS.pdf

Adapalene and benzoyl peroxide topical gel Safety Data Sheet. Adapalene and benzoyl peroxide topical gel. Strength: 0.3%/2.5% Pack Size: 45gram. Pack Size: 60 gram. NDC 72578-119-04.

10. mayoclinic.org mayoclinic.org/drugs-supplements/adapalene-topical-route/description/drg-20061544

Adapalene (topical route) - Side effects & dosage Adapalene is used to treat acne. It works partly by keeping skin pores clear. Adapalene is available only with your doctor's prescription.