← Back to Search

Topical Acne Medication

Combination Acne Therapy for Acne

Phase 4

Waitlist Available

Research Sponsored by Zeichner, Joshua, M.D.

Eligibility Criteria Checklist

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

Must have

Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence)

Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2, 4, 8, 12

Awards & highlights

Study Summary

This trial will study the use of two acne medications, clindamycin phosphate and tretinoin, when used together.

Who is the study for?

This trial is for males and females aged 12 or older with mild to moderate facial acne that's been diagnosed for at least 3 months. Participants must be in good health, not pregnant, trying to conceive, or breastfeeding, and willing to use birth control if applicable. They can't have severe acne, skin conditions affecting the study, recent antibiotic use or other acne treatments.Check my eligibility

What is being tested?

The study compares two acne treatments: one group uses a combination gel of clindamycin phosphate/tretinoin alone; another group uses this gel plus benzoyl peroxide cloths. It aims to see how effective they are when used together versus separately.See study design

What are the potential side effects?

Possible side effects include skin irritation, dryness, redness from the combination gel (clindamycin phosphate/tretinoin), and potential bleaching of hair or colored fabric by benzoyl peroxide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant and will use birth control during the study.

Select...

My skin condition is rated between mild and severe by my doctor.

Select...

I have been diagnosed with facial acne for at least 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 2, 4, 8, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 2, 4, 8, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 4, 8, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne

Secondary outcome measures

Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)

Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.

Change in Subject Self Assessment Scoring Scale

+1 more

Trial Design

2Treatment groups

Active Control

Group I: clindamycin phosphate 1.2%/tretinoin 0.025% gel aloneActive Control1 Intervention

Group II: clindamycin / tretinoin gel plus benzoyl peroxideActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zeichner, Joshua, M.D.Lead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

clindamycin phosphate 1.2%/tretinoin 0.025% gel (Topical Acne Medication) Clinical Trial Eligibility Overview. Trial Name: NCT01422785 — Phase 4

Acne Research Study Groups: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone, clindamycin / tretinoin gel plus benzoyl peroxide

Acne Clinical Trial 2023: clindamycin phosphate 1.2%/tretinoin 0.025% gel Highlights & Side Effects. Trial Name: NCT01422785 — Phase 4

clindamycin phosphate 1.2%/tretinoin 0.025% gel (Topical Acne Medication) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01422785 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the enrollment process for this research project?

"Unfortunately, this research project is not currently enrolling participants. It was first uploaded to clinicaltrials.gov on July 1st 2011 and most recently updated August 22nd 2011. However, there are 35 other medical trials actively seeking volunteers for acne studies and 37 such initiatives researching clindamycin phosphate 1.2%/tretinoin 0.025% gel exclusively that require individuals wishing to take part in them."

Answered by AI

Are there currently any openings for enrollment in this clinical trial?

"Unfortunately, this clinical trial is not in the process of recruiting participants. This research study was initially posted on July 1st 2011 and its details were last updated on August 22nd 2011. For alternatives, 35 trials for acne are currently open to applicants as well as 37 studies focused solely on clindamycin phosphate 1.2%/tretinoin 0.025% gel treatments which are also admitting volunteers at this time."

Answered by AI

Does the Food and Drug Administration recognize clindamycin phosphate 1.2%/tretinoin 0.025% gel as a valid therapeutic agent?

"There is an abundance of research demonstrating the safety of clindamycin phosphate 1.2%/tretinoin 0.025% gel, thus it earned a score of 3 on our risk assessment scale."

Answered by AI

What principal purpose does clindamycin phosphate 1.2%/tretinoin 0.025% gel fulfill?

"Clindamycin phosphate 1.2%/tretinoin 0.025% gel is the primary treatment for bacterial endocarditis and can also be applied to address keratinization disorders of the feet, bacteria, anaerobic infections, and tubo-ovarian abscesses caused by anaerobes."

Answered by AI

What empirical evidence exists regarding the effectiveness of clindamycin phosphate 1.2%/tretinoin 0.025% gel as a sole treatment?

"Currently, 37 trials are underway examining clindamycin phosphate 1.2%/tretinoin 0.025% gel exclusively, of which 11 have advanced to phase 3. Chicago is the epicentre for most investigations concerning this medication but 358 research centres across the nation are involved in these studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne

Joshua Zeichner 2011. "A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01422785.

All > New York > Acne