Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.
ClinicalTrials.gov Identifier:
NCT01362010
First received: May 26, 2011
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate the tolerability and safety and to determine whether FXFM244 Antibiotic Foam is effective in the treatment of Acne Vulgaris.


Condition Intervention Phase
Acne Vulgaris
Drug: Topical Minocycline Foam FXFM244
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study, to Evaluate the Tolerability and Safety of FXFM244 Antibiotic Foam and to Monitor Its Clinical Effect in Acne Vulgaris Patients

Resource links provided by NLM:


Further study details as provided by Foamix Ltd.:

Primary Outcome Measures:
  • Decrease in lesions count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline

  • Investigator global assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Physician's Global Improvement Assessment


Secondary Outcome Measures:
  • % change in lesions count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The % change in lesions count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline

  • Global assessment of improvement by photographs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The photographs will assist in comparison of efficacy at subsequent visits compared to baseline

  • Subject-reported outcome assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Subjects safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    safety parameters will be assessed by

    • Physical examination
    • Vital signs (HR, BP, Body temperature)
    • Adverse events recording
    • Clinical assessment of skin irritation


Enrollment: 150
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical Minocycline Foam FXFM244 - 4%
Active ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening.
Drug: Topical Minocycline Foam FXFM244
Topically applied once a day.
Other Name: FXFM244 antibiotic foam
Experimental: Topical Minocycline Foam FXFM244 - 1%
Active ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening.
Drug: Topical Minocycline Foam FXFM244
Topically applied once a day.
Other Name: FXFM244 antibiotic foam
Placebo Comparator: Placebo foam
Active ingredient: None Route: Topical Dosage schedule: Once daily, evening
Drug: Topical Minocycline Foam FXFM244
Topically applied once a day.
Other Name: FXFM244 antibiotic foam

Detailed Description:

This is a phase IIa prospective, multicenter, randomized, double blind, placebo controlled, parallel group, dose range finding clinical study to evaluate the safety, tolerability and efficacy of Minocycline Foam 1% and 4% for the treatment of Acne Vulgaris.

The study consists of a screening / baseline visit, a treatment period where patients will be treated topically on the facial skin areas affected by acne twice daily for 12 weeks, followed by a post-treatment follow up visit 4 weeks after end of treatment. The first dose will be applied in the presence of the study investigator or his assignee. Subsequent applications will be made by the patients.

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of Acne Vulgaris with facial involvement.
  • A minimum of 20 but not more than 50 inflammatory lesions on the face (papules and/ or pustules).
  • A minimum of 25 but not more than 100 non-inflammatory lesions on the face (opened and/or closed comedones).
  • No significant nodulocystic acne on the face (≤ 2 lesions).
  • A score of >3 (Moderate) on the Investigator's Global Assessment Scale.
  • Patient is male or female between the ages of 12 to 25.
  • No known medical conditions that, in the Investigator's opinion could interfere with study participation.
  • Patient is willing to refrain from use of all other topical acne medications or antibiotics during the study.
  • Patient is willing to refrain from use of moisturizers, new brands of make-up, creams, lotions, powders or any topical product other than the assigned treatment to the treatment area.
  • Patient is willing and able to comply with all requirement of the protocol.
  • Patient is willing and able to give written informed consent prior to participation in the study.
  • If female of childbearing potential, willing to use an acceptable form of birth control during the study. Use of oral contraceptives must remain constant within 3 month prior to baseline and throughout the study.

Exclusion Criteria:

  • Acne Conglobata, Acne Fulminas, secondary acne (chloracne, drug induced acne), or severe acne requiring systemic treatment.
  • Presence of any facial skin condition that would interfere with the diagnosis or assessment of Acne Vulgaris (e.g. rosacea, dermatitis, psoriasis, squamos cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
  • Excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of Acne Vulgaris.
  • Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication.
  • Concomitant medication:
  • Use within 6 month prior to baseline of topical retinoids, oral retinoids (Accutane®) or therapeutic Protocol No. FX2010-03 Foamix Ltd. Page 8 of 28 Confidential Ver: 02 Oct-31-2011 vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
  • Use of systemic steroids, systemic antibiotics, systemic treatment for Acne Vulgaris, systemic antiinflammatory agents within 4 weeks prior to baseline.
  • Use of topical steroids, α-hydroxy/glycolic acid, benzoyl peroxide, topical antibiotics, topical treatment for Acne Vulgaris, topical anti-inflammatory agents within 2 weeks prior to baseline.
  • Use for less than 3 month prior to baseline of estrogens or change in oral contraceptives therapy within less than 3 month prior to baseline;
  • Use on the face of: cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids or X-ray therapy within 4 weeks prior to baseline..
  • Alcohol or drug abuse, according to assessment by the investigator.
  • Use of another investigational drug within 30 days prior to baseline.
  • Pregnant or lactating women.
  • Use of tanning booths, sunbathing, or excessive exposure to the sun should be prohibited during the study.
  • Participation in clinical trial in the previous month.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362010

Locations
Israel
Lev Yasmin clinic
Netanya, Israel
Tel-Nordau Clalit health services
Tel-Aviv, Israel
Sourasky medical center
Tel-Aviv, Israel
Sponsors and Collaborators
Foamix Ltd.
Investigators
Principal Investigator: Joseph Shiri, Prof. Clalit Health Services
Principal Investigator: Eli Sprecher, MD Sourasky medical center
Principal Investigator: Avner Shemer, Prof. Lev Yasmin clinic, Netanya, Israel
  More Information

No publications provided

Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT01362010     History of Changes
Other Study ID Numbers: FX2010-03
Study First Received: May 26, 2011
Last Updated: August 14, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Foamix Ltd.:
Acne
Acne Vulgaris
Topical
Minocycline
Foam
Phase II

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Anti-Bacterial Agents
Minocycline
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 21, 2014