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Anti-Infective Agent

PK Cohort: ACZONE 7.5% for Acne Vulgaris

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.

Eligible Conditions

Acne Vulgaris
Acne

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1), week 12

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

Molluscum contagiosum

Impetigo

Vomiting

Pharyngitis streptococcal

Dermatitis contact

Skin pigmentation

100%

80%

60%

40%

20%

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

0 / 1Eligibility criteria met