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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: 50 mg P005672-HCl; Drug: Placebo; Drug: 100 mg P005672-HCl

• Registration Number: NCT01628549
• Lead Sponsor: Almirall, S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-26
• Study Start: 2012-06-30
• Primary Completion: 2012-11-16
• Study Completion: 2013-01-31
• Disposition First Submitted: 2013-12-11
• Disposition First Submitted QC: 2013-12-11
• Disposition First Posted: 2014-01-13
• Results First Submitted: 2018-12-18
• Results First Submitted QC: 2018-12-18
• Status Verified: 2019-01
• Results First Posted: 2019-01-08
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

• 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:

  20 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)

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P005672-HCl approximately 0.75 mg/kg/day	50 mg P005672-HCl	One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
Placebo	Placebo	Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
P005672-HCl approximately 1.5 mg/kg/day	50 mg P005672-HCl	Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks
P005672-HCl approximately 0.75 mg/kg/day	Placebo	One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks
P005672-HCl approximately 3.0 mg/kg/day	100 mg P005672-HCl	Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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	Final Visit (Up to Week 12)	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.

Secondary Outcome Measures

Name	Time	Method
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 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 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)	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.

Trial Locations

Locations (1)

Warner Chilcott Investigational Site; 🇺🇸 Lynchburg, Virginia, United States