NCT01628549|CompletedPhase 2Results

Double-Blind, Placebo-Controlled Study to Evaluate 3 Doses of a Novel Tetracycline in the Treatment of Facial Acne Vulgaris

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Different Doses of a Novel Tetracycline Compared to Placebo in the Treatment of Facial Acne Vulgaris, Study PR-10411

Almirall, S.A.ClinicalTrials.gov

Compare

1 other identifier

PR-10411

Study Type

interventional

Target

285

Locations

1 country

Sites

Timeline

RegisteredJun 2012

StartedJun 2012

CompletionJan 2013

Brief Summary

To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

285

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach

1 country

38 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

First Submitted

Initial submission to the registry

June 22, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2012

Completed

4 days until next milestone

Study Start

First participant enrolled

June 30, 2012

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2012

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2013

Completed

5.9 years until next milestone

Results Posted

Study results publicly available

January 8, 2019

Completed

Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

June 22, 2012

Results QC Date

December 18, 2018

Last Update Submit

January 31, 2019

Conditions

Acne Vulgaris

Keywords

acne

Outcome Measures

Primary Outcomes (2)

The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Baseline (Week 0) to Final Visit (Up to Week 12)
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Final Visit (Up to Week 12)

Secondary Outcomes (5)

The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Baseline (Week 0) up to Week 12
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Baseline (Week 0) up to Week 12
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Baseline (Week 0) up to Week 12
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
Baseline to Final Visit (Up to Week 12)

Study Arms (4)

P005672-HCl approximately 0.75 mg/kg/day

EXPERIMENTAL

One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks

Drug: 50 mg P005672-HClDrug: Placebo

P005672-HCl approximately 1.5 mg/kg/day

EXPERIMENTAL

Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks

Drug: 50 mg P005672-HCl

P005672-HCl approximately 3.0 mg/kg/day

EXPERIMENTAL

Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks

Drug: 100 mg P005672-HCl

Placebo

PLACEBO COMPARATOR

Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks

Drug: Placebo

Interventions

50 mg P005672-HClDRUG

P005672-HCl administered as an oral capsule(s) once daily

Also known as: WC3035, Sarecycline

P005672-HCl approximately 0.75 mg/kg/dayP005672-HCl approximately 1.5 mg/kg/day

PlaceboDRUG

Dose-matched Placebo capsule administered as an oral capsule(s) once daily

Also known as: Inactive

P005672-HCl approximately 0.75 mg/kg/dayPlacebo

100 mg P005672-HClDRUG

P005672-HCl administered as an oral capsule(s) once daily

Also known as: WC3035, Sarecycline

P005672-HCl approximately 3.0 mg/kg/day

Eligibility Criteria

Age12 Years - 45 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

if women of child-bearing potential, have a negative urine pregnancy test
Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study
Male or female, 12-45 years of age with body weight between 52 and 88 kg
Diagnosis of acne vulgaris with:
to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones)
No more than 2 nodules on the face
Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)

You may not qualify if:

Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible:
Within 1 week prior to randomization:
Medicated facial cleansers
Topical acne treatments (other than those listed below)
Within 4 weeks prior to randomization:
Topical retinoids
Topical anti-inflammatories and corticosteroids
Systemic antibiotics
Systemic acne treatments
Within 12 weeks prior to randomization:
Systemic retinoids
Systemic corticosteroids
Pseudomembranous colitis or antibiotic-associated colitis
Hepatitis, liver damage or renal impairment

Contact the study team to confirm eligibility.