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

Almirall

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: 50 mg P005672-HCl; Drug: Placebo; Drug: 100 mg P005672-HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01628549

PR-10411

Details and patient eligibility

About

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.

Enrollment: 285 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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285 participants in 4 patient groups, including a placebo group

P005672-HCl approximately 0.75 mg/kg/day

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: 50 mg P005672-HCl

P005672-HCl approximately 1.5 mg/kg/day

Experimental group

Description:

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

Treatment:

Drug: 50 mg P005672-HCl

P005672-HCl approximately 3.0 mg/kg/day

Experimental group

Description:

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

Treatment:

Drug: 100 mg P005672-HCl

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo