--- title: Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris nct_id: NCT04214639 overall_status: COMPLETED phase: PHASE3 sponsor: Bausch Health Americas, Inc. study_type: INTERVENTIONAL primary_condition: Acne Vulgaris countries: United States, Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04214639.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04214639" ct_last_update_post_date: 2024-02-01 last_seen_at: "2026-05-12T07:13:45.214Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris **Official Title:** A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris **NCT ID:** [NCT04214639](https://clinicaltrials.gov/study/NCT04214639) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 183 - **Lead Sponsor:** Bausch Health Americas, Inc. - **Conditions:** Acne Vulgaris - **Start Date:** 2020-01-17 - **Completion Date:** 2021-01-18 - **CT.gov Last Update:** 2024-02-01 ## Brief Summary This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. ## Eligibility - **Minimum age:** 9 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Male or female at least 9 years of age and older. * Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit). * Subject must have an Evaluator's Global Severity Score (EGSS) of 3 (moderate) or 4 (severe) at the baseline visit. * Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100. * Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150. * Subjects with 2 or fewer facial nodules. Exclusion Criteria: * Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema. * Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * Subjects with more than 2 facial nodules. * Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study. * Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study. * Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area. * Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area. * Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications. * Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study. ``` ## Arms - **IDP-126 Gel** (EXPERIMENTAL) - **IDP-126 Vehicle Gel** (PLACEBO_COMPARATOR) ## Interventions - **IDP-126 Gel** (DRUG) — IDP-126 Gel applied topically to the face once daily for 12 weeks. - **IDP-126 Vehicle Gel** (DRUG) — IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks. ## Primary Outcomes - **Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts** _(time frame: 12 weeks)_ - **Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts** _(time frame: 12 weeks)_ - **Percentage of Participants With Success on the Evaluator's Global Severity Score** _(time frame: 12 weeks)_ — Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity. ## Secondary Outcomes - **Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12** _(time frame: Baseline to Week 4, 8, 12)_ - **Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12** _(time frame: Baseline to Week 4, 8, 12)_ - **Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12** _(time frame: 12 weeks)_ ## Locations (13) - Bausch Site 110, Bryant, Arkansas, United States - Bausch Site 104, Fremont, California, United States - Bausch Site 109, Denver, Colorado, United States - Bausch Site 102, Boynton Beach, Florida, United States - Bausch Site 111, North Miami Beach, Florida, United States - Bausch Site 106, Sanford, Florida, United States - Bausch Site 103, Las Vegas, Nevada, United States - Bausch Site 114, New York, New York, United States - Bausch Site 105, High Point, North Carolina, United States - Bausch Site 107, Nashville, Tennessee, United States - Bausch Site 108, Pflugerville, Texas, United States - Bausch Site 101, Barrie, Ontario, Canada - Bausch Site 113, Waterloo, Ontario, Canada ## Recent Field Changes (last 30 days) - `sponsor.lead` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `armsInterventions.interventions` — 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)_ - `design.enrollmentCount` — 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)_ - `locations.bausch site 110|bryant|arkansas|united states` — added _(2026-05-12)_ - `locations.bausch site 104|fremont|california|united states` — added _(2026-05-12)_ - `locations.bausch site 109|denver|colorado|united states` — added _(2026-05-12)_ - `locations.bausch site 102|boynton beach|florida|united states` — added _(2026-05-12)_ - `locations.bausch site 111|north miami beach|florida|united states` — added _(2026-05-12)_ - `locations.bausch site 106|sanford|florida|united states` — added _(2026-05-12)_ - `locations.bausch site 103|las vegas|nevada|united states` — added _(2026-05-12)_ - `locations.bausch site 114|new york|new york|united states` — added _(2026-05-12)_ - `locations.bausch site 105|high point|north carolina|united states` — added _(2026-05-12)_ - `locations.bausch site 107|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.bausch site 108|pflugerville|texas|united states` — added _(2026-05-12)_ - `locations.bausch site 101|barrie|ontario|canada` — added _(2026-05-12)_ - `locations.bausch site 113|waterloo|ontario|canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT04214639.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT04214639* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*