Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel and Vehicle Gel
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| ClinicalTrials.gov Identifier: NCT04892706 |
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Recruitment Status :
Completed
First Posted : May 19, 2021
Last Update Posted : October 18, 2022
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Sponsor:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.
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Brief Summary:
The safety and efficacy of once daily application of IDP 126 Gel will be compared to Epiduo® Forte and IDP-126 Vehicle Gel.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acne Vulgaris | Drug: IDP-126 Gel Drug: IDP-126 Vehicle Gel Drug: Epiduo® Forte Gel | Phase 2 |
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 with Epiduo® Forte gel and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible for the study, subjects must be at least 12 years of age and have a clinical diagnosis of moderate to severe acne (defined as an Evaluator's Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 686 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris |
| Actual Study Start Date : | June 11, 2021 |
| Actual Primary Completion Date : | September 28, 2022 |
| Actual Study Completion Date : | September 28, 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: IDP-126 Gel |
Drug: IDP-126 Gel
Gel applied to face once daily in the evening.
Other Name: IDP-126 |
| Placebo Comparator: IDP-126 Vehicle Gel |
Drug: IDP-126 Vehicle Gel
Gel applied to face once daily in the evening.
Other Name: Vehicle |
| Active Comparator: Epiduo® Forte Gel |
Drug: Epiduo® Forte Gel
Gel applied to face once daily in the evening.
Other Name: Epiduo® Forte |
Primary Outcome Measures :
- Absolute change from Baseline to Week 12 in lesion counts. [ Time Frame: Baseline to Week 12 ]
- Percentage of subjects who achieve at least a two-grade reduction from baseline and are "Clear" or "Almost Clear" at Week 12 in the Evaluator's Global Severity Score. [ Time Frame: Baseline to Week 12 ]EGSS evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being severe.
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| Ages Eligible for Study: | 12 Years to 99 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female at least 12 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 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04892706
Locations
Show 42 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
| Study Director: | Varsha Bhatt | Bausch Health Americas, Inc. |
| Responsible Party: | Bausch Health Americas, Inc. |
| ClinicalTrials.gov Identifier: | NCT04892706 |
| Other Study ID Numbers: |
V01-126A-202 |
| First Posted: | May 19, 2021 Key Record Dates |
| Last Update Posted: | October 18, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Adapalene, Benzoyl Peroxide Drug Combination Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents |