Clinical Study to Evaluate Tolerability and Safety of FXFM244 and to Monitor Clinical Effect in Acne Vulgaris Patients
Information source: Foamix Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Topical Minocycline Foam FXFM244 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Foamix Ltd. Official(s) and/or principal investigator(s): Joseph Shiri, Prof., Principal Investigator, Affiliation: Clalit Health Services Eli Sprecher, MD, Principal Investigator, Affiliation: Sourasky medical center Avner Shemer, Prof., Principal Investigator, Affiliation: Lev Yasmin clinic, Netanya, Israel
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Decrease in lesions countInvestigator global assessment
Secondary outcome: % change in lesions countGlobal assessment of improvement by photographs Subject-reported outcome assessment Subjects safety
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
Minimum age: 12 Years.
Maximum age: 25 Years.
Gender(s): Both.
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.
Locations and Contacts
Lev Yasmin clinic, Netanya, Israel
Sourasky medical center, Tel-Aviv, Israel
Tel-Nordau Clalit health services, Tel-Aviv, Israel
Additional Information
Starting date: January 2012
Last updated: August 14, 2013
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