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

NCT01362010 | Completed Phase 2

• 1 other identifier: FX2010-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acne Vulgaris

Keywords

Acne; Acne Vulgaris; Topical; Minocycline; Foam; Phase II

Outcome Measures

Primary Outcomes (2)

• Decrease in lesions count

  The change in lesion count (inflammatory, non-inflammatory, and total) after 12 weeks of treatment compared to baseline

  12 weeks

• Investigator global assessment

  Physician's Global Improvement Assessment

  12 weeks

Secondary Outcomes (4)

• % change in lesions count

  12 weeks

• Global assessment of improvement by photographs

  12 weeks

• Subject-reported outcome assessment

  12 weeks

• Subjects safety

  12 weeks

Study Arms (3)

Topical Minocycline Foam FXFM244 - 4%

EXPERIMENTAL

Active ingredient: Minocycline Concentration: 4% Route: Topical Dosage schedule: Once daily, evening.

Drug: Topical Minocycline Foam FXFM244

Topical Minocycline Foam FXFM244 - 1%

EXPERIMENTAL

Active ingredient: Minocycline Concentration: 1% Route: Topical Dosage schedule: Once daily, evening.

Drug: Topical Minocycline Foam FXFM244

Placebo foam

PLACEBO COMPARATOR

Active ingredient: None Route: Topical Dosage schedule: Once daily, evening

Drug: Topical Minocycline Foam FXFM244

Interventions

Topical Minocycline Foam FXFM244 DRUG

Topically applied once a day.

Also known as: FXFM244 antibiotic foam

Placebo foam; Topical Minocycline Foam FXFM244 - 1%; Topical Minocycline Foam FXFM244 - 4%

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (3)

Lev Yasmin clinic

Netanya, Israel

Location

Sourasky medical center

Tel Aviv, Israel

Location

Tel-Nordau Clalit health services

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Acne Vulgaris; cyclopia sequence

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Joseph Shiri, Prof.

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

• Eli Sprecher, MD

  Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

• Avner Shemer, Prof.

  Lev Yasmin clinic, Netanya, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: May 27, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

IL (3)