Topical Acne Medications for Acne

Recruiting in Palo Alto (17 mi)

Overseen by Steven Feldman, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 18, No acne, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2

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.

What data supports the idea that Topical Acne Medications for Acne is an effective treatment?

The available research shows that topical acne medications, specifically combinations of clindamycin phosphate and benzoyl peroxide, are effective for treating acne. Studies have demonstrated that these combinations, such as clindamycin phosphate 1.2% with benzoyl peroxide 2.5% or 3.75%, improve acne conditions in patients with moderate to severe acne. Additionally, a study comparing clindamycin/benzoyl peroxide gel to adapalene/benzoyl peroxide gel found both to be effective, but the combination gel was noted for its tolerability. Overall, these studies support the effectiveness of these topical medications in reducing acne symptoms. ^{1 2 3 4 5}

What safety data is available for topical acne medications?

The safety and tolerability of clindamycin phosphate and benzoyl peroxide gel combinations have been evaluated in several studies. These studies generally report that the combination gels are safe and well-tolerated for the treatment of moderate to severe acne vulgaris. Common side effects include erythema, dryness, peeling, pruritus, and burning/stinging, with some formulations being better tolerated than others. Overall, the combination of clindamycin and benzoyl peroxide is considered safe for use in acne treatment. ^{4 5 6 7 8}

Is the drug Adapalene Gel, Clindamycin Phosphate/Benzoyl Peroxide Gel a promising treatment for acne?

Yes, the drug is promising for treating acne. Studies show that the combination of clindamycin and benzoyl peroxide is effective for moderate to severe acne. It is well-tolerated and can be used as a maintenance therapy to prevent acne from coming back. This makes it a strong option for managing acne. ^{1 4 5 6 9}

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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 who live in the US

Patients have sufficient command of the English language

I am 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Adapalene Gel (Topical Retinoid)
• Clindamycin Phosphate/Benzoyl Peroxide Gel (Topical Antibiotic)

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.

Participant Groups

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 Canada, Japan for the following indications:

Approved in Canada as Differin for:

• Acne vulgaris

Approved in Japan as Differin for:

• Acne vulgaris

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Wake Forest University Health Sciences Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1432

Patients Recruited

2,506,000+

Bausch Health Americas, Inc.

Industry Sponsor

Trials

265

Patients Recruited

82,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. United States 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. [2021]

2. United States 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. [2015]

3. England 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. [2015]

4. United States 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. [2014]

5. United States 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. [2015]

6. United States 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. [2020]

7. United States 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. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Management of Severe Acne Vulgaris With Topical Therapy. [2022]