--- title: A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris nct_id: NCT03271021 overall_status: COMPLETED phase: PHASE3 sponsor: Vyne Therapeutics Inc. study_type: INTERVENTIONAL primary_condition: Acne Vulgaris countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03271021.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03271021" ct_last_update_post_date: 2022-01-18 last_seen_at: "2026-05-12T06:39:25.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris **Official Title:** A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22) **NCT ID:** [NCT03271021](https://clinicaltrials.gov/study/NCT03271021) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 1488 - **Lead Sponsor:** Vyne Therapeutics Inc. - **Conditions:** Acne Vulgaris - **Start Date:** 2017-07-17 - **Completion Date:** 2018-09-04 - **CT.gov Last Update:** 2022-01-18 ## Brief Summary A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22) ## Detailed Description This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments: * FMX101 4% minocycline foam * Vehicle foam ## Eligibility - **Minimum age:** 9 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Has facial acne vulgaris with: 1. 20 to 50 inflammatory lesions (papules, pustules, and nodules) 2. 25 to 100 non-inflammatory lesions (open and closed comedones) 3. No more than 2 nodules on the face 4. IGA score of moderate (3) to severe (4) 2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin 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. Exclusion Criteria: 1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations. 2. Sunburn on the face. ``` ## Arms - **FMX101, 4% minocycline foam** (EXPERIMENTAL) — FMX101, 4% minocycline foam applied topically once daily for 12 weeks - **Vehicle foam** (PLACEBO_COMPARATOR) — Vehicle foam applied topically once daily for 12 weeks ## Interventions - **FMX101** (DRUG) — FMX101, 4% minocycline foam - **Vehicle Foam** (DRUG) — Vehicle Foam ## Primary Outcomes - **The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.** _(time frame: 12 weeks)_ — A decrease in the inflammatory lesion count from Baseline to Week 12. - **Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline** _(time frame: 12 weeks)_ ## Secondary Outcomes - **The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12** _(time frame: 12 weeks)_ - **The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9** _(time frame: 9 weeks)_ - **The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6** _(time frame: 6 weeks)_ - **IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6** _(time frame: 6 weeks)_ - **IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9** _(time frame: 9 weeks)_ ## Locations (98) - Foamix Investigational Site #376, Phoenix, Arizona, United States - Foamix Investigational Site #395, Tucson, Arizona, United States - Foamix Investigational Site #315, Bryant, Arkansas, United States - Foamix Investigational Site #340, Fort Smith, Arkansas, United States - Foamix Investigational SIte #377, Little Rock, Arkansas, United States - Foamix Investigational Site #366, Encino, California, United States - Foamix Investigational Site #403, Los Angeles, California, United States - Foamix Investigational Site #303, Murrieta, California, United States - Foamix Investigational Site #369, Northridge, California, United States - Foamix Investigational Site #387, Palm Springs, California, United States - Foamix Investigational Site #393, Pasadena, California, United States - Foamix Investigational Site #380, Poway, California, United States - Foamix Investigational Site # 328, Sacramento, California, United States - Foamix Investigational Site #313, San Diego, California, United States - Foamix Investigational Site #336, San Luis Obispo, California, United States - Foamix Investigational Site #309, Santa Ana, California, United States - Foamix Investigational Site #325, Santa Monica, California, United States - Foamix Investigational Site #375, Temecula, California, United States - Foamix Investigational Site #381, Aventura, Florida, United States - Foamix Investigational SIte #371, Boca Raton, Florida, United States - Foamix Investigational Site #311, Boca Raton, Florida, United States - Foamix Investigational Site #398, Brandon, Florida, United States - Foamix Investigational Site #329, Clearwater, Florida, United States - Foamix Investigational Site #378, Davie, Florida, United States - Foamix Investigational Site #396, DeLand, Florida, United States - Foamix Investigational Site #392, Doral, Florida, United States - Foamix Investigational Site #318, Fort Myers, Florida, United States - Foamix Investigational Site #401, Hialeah, Florida, United States - Foamix Investigational Site #400, Hialeah, Florida, United States - Foamix Investigational Site #383, Lake Worth, Florida, United States - Foamix Investigational Site #397, Miami, Florida, United States - Foamix Investigational Site #370, Miami, Florida, United States - Foamix Investigational Site #346, Miami Lakes, Florida, United States - Foamix Investigational Site #347, Miami Lakes, Florida, United States - Foamix Investigational Site #306, North Miami Beach, Florida, United States - Foamix Investigational Site #312, Ormond Beach, Florida, United States - Foamix Investigational Site #362, South Miami, Florida, United States - Foamix Investigational SIte #382, Tamarac, Florida, United States - Foamix Investigational Site #399, Tampa, Florida, United States - Foamix Investigational Site #385, Tampa, Florida, United States - Foamix Investigational Site #394, Tampa, Florida, United States - Foamix Investigational Site #360, West Palm Beach, Florida, United States - Foamix Investigational Site #368, Columbus, Georgia, United States - Foamix Investigational Site #336, Sandy Springs, Georgia, United States - Foamix Investigational Site #384, Nampa, Idaho, United States - Foamix Investigational Site #345, Skokie, Illinois, United States - Foamix Investigational Site #390, West Dundee, Illinois, United States - Foamix Investigational Site #365, Indianapolis, Indiana, United States - Foamix Investigational Site #316, New Albany, Indiana, United States - Foamix Investigational Site #361, Plainfield, Indiana, United States - Foamix Investigational Site #331, South Bend, Indiana, United States - Foamix Investigational Site #320, Louisville, Kentucky, United States - Foamix Investigational SIte #367, Louisville, Kentucky, United States - Foamix Investigational Site #317, New Orleans, Louisiana, United States - Foamix Investigational SIte #373, New Orleans, Louisiana, United States - Foamix Investigational Site #388, Glenn Dale, Maryland, United States - Foamix Investigational Site #304, Beverly, Massachusetts, United States - Foamix Investigational Site #314, Brighton, Massachusetts, United States - Foamix Investigational Site #334, Watertown, Massachusetts, United States - Foamix Investigational Site #322, Saint Joseph, Missouri, United States - Foamix Investigational Site #372, St Louis, Missouri, United States - Foamix Investigational Site #391, Lincoln, Nebraska, United States - Foamix Investigational Site # 327, Omaha, Nebraska, United States - Foamix Investigational Site #332, Las Vegas, Nevada, United States - Foamix Investigational Site #344, Portsmouth, New Hampshire, United States - Foamix Investigational Site #356, Berlin, New Jersey, United States - Foamix Investigational Site #337, Verona, New Jersey, United States - Foamix Investigational Site #321, Charlotte, New York, United States - Foamix Investigational Site #355, New York, New York, United States - Foamix Investigational Site #363, New York, New York, United States - Foamix Investigational Site #307, Stony Brook, New York, United States - Foamix Investigational Site #350, Charlotte, North Carolina, United States - Foamix Investigational Site #348, Winston-Salem, North Carolina, United States - Foamix Investigational Site #364, Fargo, North Dakota, United States - Foamix Investigational Site #310, Bexley, Ohio, United States - Foamix Investigational Site #386, Cincinnati, Ohio, United States - Foamix Investigational Site #353, Cleveland, Ohio, United States - Foamix Investigational Site #330, Dublin, Ohio, United States - Foamix Investigational Site #302, Norman, Oklahoma, United States - Foamix Investigational Site #335, Exton, Pennsylvania, United States - Foamix Investigational Site #349, Hershey, Pennsylvania, United States - Foamix Investigational Site #323, Jenkintown, Pennsylvania, United States - Foamix Investigational Site #319, Charleston, South Carolina, United States - Foamix Investigational Site #305, Mt. Pleasant, South Carolina, United States - Foamix Investigational Site #308, Knoxville, Tennessee, United States - Foamix Research Site # 301, Arlington, Texas, United States - Foamix Investigational Site #374, Arlington, Texas, United States - Foamix Investigational SIte #341, Austin, Texas, United States - Foamix Investigational Site #351, Austin, Texas, United States - Foamix Investigational Site #402, Bryan, Texas, United States - Foamix Investigational Site #358, Dallas, Texas, United States - Foamix Investigational Site #333, Houston, Texas, United States - Foamix Investigational Site #352, Houston, Texas, United States - Foamix Investigational Site # 324, Pflugerville, Texas, United States - Foamix Investigational SIte #379, Lynchburg, Virginia, United States - Foamix Investigational Site #343, Norfolk, Virginia, United States - Foamix Investigational Site #389, Seattle, Washington, United States - Foamix Investigational Site #359, Tacoma, Washington, United States ## Recent Field Changes (last 30 days) - `locations.foamix investigational site #330|dublin|ohio|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #302|norman|oklahoma|united states` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.foamix investigational site #369|northridge|california|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.foamix investigational site #376|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #395|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #315|bryant|arkansas|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #340|fort smith|arkansas|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #377|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #366|encino|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #403|los angeles|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #303|murrieta|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #387|palm springs|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #393|pasadena|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #380|poway|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site # 328|sacramento|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #313|san diego|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #336|san luis obispo|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #309|santa ana|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #325|santa monica|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #375|temecula|california|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #381|aventura|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #371|boca raton|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #311|boca raton|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #398|brandon|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #329|clearwater|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #378|davie|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #396|deland|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #392|doral|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #318|fort myers|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #401|hialeah|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #400|hialeah|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #383|lake worth|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #397|miami|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #370|miami|florida|united states` — added _(2026-05-12)_ - `locations.foamix investigational site #346|miami lakes|florida|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03271021.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03271021* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*