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Anti-Infective Agent

PK Cohort: ACZONE 7.5% for Acne

Phase 4
Waitlist Available
Research Sponsored by Almirall, S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), week 12
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), 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
Change From Baseline in Body Temperature
Change From Baseline in Heart Rate
Change From Baseline in Height
+6 more
Other study objectives
Absolute Change From Baseline in Inflammatory Lesion Counts
Absolute Change From Baseline in Non-inflammatory Lesion Counts
Absolute Change From Baseline in Total Lesion Counts on Face
+7 more

Side effects data

From 2018 Phase 4 trial • 100 Patients • NCT02959970
6%
Molluscum contagiosum
6%
Impetigo
6%
Vomiting
6%
Pharyngitis streptococcal
6%
Dermatitis contact
6%
Skin pigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
PK Cohort
Non-PK Cohort

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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

2Treatment groups
Experimental Treatment
Group I: PK Cohort: ACZONE 7.5%Experimental Treatment1 Intervention
Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks.
Group II: Non-PK Cohort: ACZONE 7.5%Experimental Treatment1 Intervention
Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapsone
FDA approved

Find a Location

Who is running the clinical trial?

Almirall, S.A.Lead Sponsor
61 Previous Clinical Trials
18,146 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
276,554 Total Patients Enrolled
Cathy TruongStudy DirectorAllergan
~11 spots leftby Oct 2025
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