Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03276936
Other study ID # FX2016-13
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 5, 2017
Est. completion date January 15, 2019

Study information

Verified date January 2022
Source Vyne Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.


Description:

This is an open-label, multicenter, 40-week extension study to evaluate the long-term safety, tolerability, and efficacy of FMX103 1.5% topical foam in the treatment of moderate-to-severe facial papulopustular rosacea. Subjects entering this study will have recently participated in 1 of 2 pivotal, double-blind, vehicle-controlled, safety and efficacy studies (FX2016-11 and FX2016-12 - NCT03142451). Subjects must demonstrate that they are eligible to continue into Study FX2016-13 based on safety evaluations and IGA score performed at Final Visit of one of the previous double-blind studies. At the completion of the Final Visit in Study FX2016-11 or Study FX2016-12, subjects may be invited to continue into this open-label study for an additional 40 weeks of open-label treatment. A minimum of 400 subjects will be enrolled into from Studies FX2016-11 and FX2016-12. Subjects who elect to continue into this open-label study will receive supplies of active FMX103 1.5% minocycline foam.


Recruitment information / eligibility

Status Completed
Enrollment 504
Est. completion date January 15, 2019
Est. primary completion date January 3, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Have completed 12 weeks of treatment in either Study FX2016-11 or Study FX2016-12. 2. Have not had a worsening of disease, determined by the Investigator's Global Assessment (IGA), at Visit 5/Week 12 (Final Visit) relative to the Day 0/Baseline assessment in Study FX2016-11 or Study FX2016-12. Exclusion Criteria: 1. Have a new systemic disease or condition, including an ongoing AE that might interfere with the conduct of the study or the interpretation of results. 2. Have developed a condition that would have been exclusionary for Study FX2016-11 or Study FX2016-12, including pseudomembranous colitis, antibiotic associated colitis, hepatitis, liver damage, renal impairment, drug addiction, or alcohol abuse.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FMX103 1.5%
FMX103 1.5% minocycline foam

Locations

Country Name City State
United States Foamix Investigational Site # 118 Alpharetta Georgia
United States Foamix Investigational Site # 137 Ann Arbor Michigan
United States Foamix Investigational Site # 219 Arlington Texas
United States Foamix Investigational Site # 211 Arlington Heights Illinois
United States Foamix Investigational Site # 117 Austin Texas
United States Foamix Investigational Site # 132 Austin Texas
United States Foamix Investigational Site # 242 Bay City Michigan
United States Foamix Investigational Site # 110 Beverly Massachusetts
United States Foamix Investigational Site # 101 Bexley Ohio
United States Foamix Investigational Site # 223 Boca Raton Florida
United States Foamix Investigational Site # 215 Boynton Beach Florida
United States Foamix Investigational Site # 107 Brighton Massachusetts
United States Foamix Investigational Site # 231 Charleston South Carolina
United States Foamix Investigational Site # 119 Charlotte North Carolina
United States Foamix Investigational Site # 109 Clearwater Florida
United States Foamix Investigational Site # 227 Denver Colorado
United States Foamix Investigational Site # 210 Detroit Michigan
United States Foamix Investigational Site # 128 Dublin Ohio
United States Foamix Investigational Site # 224 Exton Pennsylvania
United States Foamix Investigational Site # 103 Fort Gratiot Michigan
United States Foamix Investigational Site # 240 Fort Myers Florida
United States Foamix Investigational Site # 127 Fremont California
United States Foamix Investigational Site # 232 Fridley Minnesota
United States Foamix Investigational Site # 207 Glendale Arizona
United States Foamix Investigational Site # 106 Greenville South Carolina
United States Foamix Investigational Site # 112 Hialeah Florida
United States Foamix Investigational Site # 238 High Point North Carolina
United States Foamix Investigational Site # 202 Hot Springs Arkansas
United States Foamix Investigational Site # 201 Houston Texas
United States Foamix Investigational Site # 141 Jenkintown Pennsylvania
United States Foamix Investigational Site # 105 Johnston Rhode Island
United States Foamix Investigational Site # 228 Knoxville Tennessee
United States Foamix Investigational Site # 221 Las Vegas Nevada
United States Foamix Investigational Site # 226 Los Angeles California
United States Foamix Investigational Site # 235 Louisville Kentucky
United States Foamix Investigational Site # 237 Louisville Kentucky
United States Foamix Investigational Site # 216 Lynchburg Virginia
United States Foamix Investigational Site # 102 Metairie Louisiana
United States Foamix Investigational Site # 214 Miami Florida
United States Foamix Investigational Site # 230 Mount Pleasant South Carolina
United States Foamix Investigational Site # 220 Murrieta California
United States Foamix Investigational Site # 138 New Albany Indiana
United States Foamix Investigational Site # 115 New Orleans Louisiana
United States Foamix Investigational Site # 136 New York New York
United States Foamix Investigational Site # 225 Newburgh Indiana
United States Foamix Investigational Site # 204 Newnan Georgia
United States Foamix Investigational Site # 236 Norman Oklahoma
United States Foamix Investigational Site # 241 North Miami Beach Florida
United States Foamix Investigational Site # 131 Oceanside California
United States Foamix Investigational Site # 133 Omaha Nebraska
United States Foamix Investigational Site # 104 Ormond Beach Florida
United States Foamix Investigational Site # 206 Pflugerville Texas
United States Foamix Investigational Site # 212 Raleigh North Carolina
United States Foamix Investigational Site # 222 Rogers Arkansas
United States Foamix Investigational Site # 134 Sacramento California
United States Foamix Investigational Site # 130 Saint Joseph Missouri
United States Foamix Investigational Site # 126 Salt Lake City Utah
United States Foamix Investigational Site # 108 San Antonio Texas
United States Foamix Investigational Site # 208 San Antonio Texas
United States Foamix Investigational Site # 213 San Antonio Texas
United States Foamix Investigational Site # 114 San Diego California
United States Foamix Investigational Site # 116 San Luis Obispo California
United States Foamix Investigational Site # 233 Sandy Springs Georgia
United States Foamix Investigational Site # 121 Sanford Florida
United States Foamix Investigational Site # 135 Santa Ana California
United States Foamix Investigational Site # 123 Santa Monica California
United States Foamix Investigational Site # 203 Seattle Washington
United States Foamix Investigational Site # 139 Snellville Georgia
United States Foamix Investigational Site # 218 South Bend Indiana
United States Foamix Investigational Site # 111 Stony Brook New York
United States Foamix Investigational Site # 125 Tampa Florida
United States Foamix Investigational Site # 239 Temecula California
United States Foamix Investigational Site # 120 Troy Michigan
United States Foamix Investigational Site # 140 Warren Michigan
United States Foamix Investigational Site # 229 Watertown Massachusetts
United States Foamix Investigational Site # 209 Webster Texas
United States Foamix Investigational Site # 124 West Palm Beach Florida
United States Foamix Investigational Site # 234 Winston-Salem North Carolina
United States Foamix Investigational Site # 129 Yardley Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absolute Change From Baseline in Inflammatory Lesion Count at Week 40 Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Week 40
Primary Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 40 The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. At Week 40
Secondary Absolute Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Secondary Percentage of Participants Achieving IGA Treatment Success at Weeks 4, 10, 16, 22, 28 and 34 The IGA scale for Rosacea, was used by the Investigators to assess the severity of a participant's Rosacea. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline. At Weeks 4, 10, 16, 22, 28 and Week 34
Secondary Percentage Change From Baseline in Inflammatory Lesion Count at Weeks 4, 10, 16, 22, 28, and 34 Change from Baseline (Baseline visit in the initial DB study [FX2016-11 or FX2016-12] and Baseline visit of the open-label extension study [Week 12]) in inflammatory lesion count at Week 40 is reported. The lesion counts performed at Week 12 [Final Visit] in Study FX2016-11 or Study FX2016-12 constituted as the Baseline value for this study. Changes from Baseline were calculated as the Baseline [pre-dose] value minus the post-Baseline value, so that decreases reflected a reduction in lesion count. The number of papules, pustules, and nodules were counted, and the numbers recorded. Day 0/ Baseline (Final visit of previous DB study [Week 12]) and at Weeks 4, 10, 16, 22, 28, and 34
Secondary Number of Participants Reporting Satisfaction and Dissatisfaction With the Study Drug Based on Subject Satisfaction Questionnaire (SSQ) at Week 40 The questionnaire consisted of questions with responses on scale with scores: as 1 (Very satisfied or Very likely ) to 5 (Very dissatisfied or Very unlikely) for each variable as for example, Easy to use, 1 is very satisfied and 5 is very dissatisfied. The minimum score represented best outcome and higher score represented worst outcome. At Week 40
Secondary Number of Participants With Adverse Events (AEs) Evaluation of the long-term safety of topical FMX103 1.5% minocycline foam in the treatment of moderate to severe facial papulopustular rosacea for 40 weeks. A Treatment-emergent Adverse Events (TEAEs) was defined as any AE with an onset date after the first dose date of the open-label extension study and before the last application of study drug plus 3 days having been absent pre-treatment or worsened relative to the pre-treatment state. Day 0/ Baseline (Final visit of previous DB study [Week 12]) until safety follow-up (Week 44)
See also
  Status Clinical Trial Phase
Completed NCT02601963 - Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea Phase 2
Completed NCT02268474 - Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea N/A
Completed NCT01555463 - Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea Phase 3
Active, not recruiting NCT03667222 - Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea Phase 2
Terminated NCT03564145 - A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea Phase 3
Completed NCT05150587 - Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea Phase 2
Completed NCT03263273 - Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea Phase 2
Completed NCT05343455 - A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) Phase 3
Completed NCT01784133 - A Twelve Week Safety and Efficacy Study in Rosacea Phase 2
Completed NCT01872715 - Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea Phase 4
Completed NCT05296629 - A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. Phase 3
Completed NCT05838170 - Study of TP-04 in Participants With Papulopustular Rosacea Phase 2
Recruiting NCT06013371 - PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea Phase 2
Recruiting NCT03864978 - Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test Phase 2
Completed NCT03564119 - A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea Phase 3
Completed NCT03079531 - Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea Phase 1/Phase 2
Completed NCT01045551 - Open Label Pilot Study of Apremilast in Treatment of Rosacea Phase 2
Completed NCT03448939 - A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea Phase 3
Completed NCT05675501 - Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties Phase 1
Withdrawn NCT03883945 - A Safety and Efficacy Study to Evaluate Rosacea Phase 1/Phase 2