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Anti-acne medication

A Treatment for Severe Inflammatory Acne Subjects

Phase 4

Waitlist Available

Research Sponsored by Galderma Laboratories, L.P.

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 4, 8, and 12

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Approved for 60 Other Conditions

Drug Has Already Been Approved

Summary

Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.

Eligible Conditions

Acne Vulgaris
Acne

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4, 8, and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 4, 8, and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, and 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 in Number of Inflammatory Lesions

Secondary study objectives

Change From Baseline in Inflammatory Lesion Count

Change From Baseline in Non-Inflammatory Lesion Count

Change From Baseline in Total Lesion Count

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Acne treatmentExperimental Treatment2 Interventions

Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks) Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adapalene

FDA approved

Doxycycline

FDA approved

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