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A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV) (DUAL)

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Trifarotene cream
Doxycycline hyclate
Trifarotene Vehicle
Doxycycline Placebo
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4 (Severe)
  • Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to 120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2 nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose
  • Agrees to provide written informed consent
  • Participant is a female of non-childbearing potential (premenarchal or postmenopausal [absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason], hysterectomy or bilateral oophorectomy)

Exclusion Criteria:

  • Participant with any acne cyst on the face
  • Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
  • Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator
  • Participants who is at risk in terms of precautions, warnings, and contraindications for trifarotene or doxycycline hyclate
  • Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).

Sites / Locations

  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site
  • Galderma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trifarotene Cream + Doxycycline

Trifarotene Vehicle + Doxycycline Placebo

Arm Description

Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.

Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.

Secondary Outcome Measures

Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12
IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.

Full Information

First Posted
June 25, 2020
Last Updated
April 20, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT04451330
Brief Title
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
Acronym
DUAL
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study To Compare Efficacy and Safety of Trifarotene (CD5789) Cream When Used Withan Oral Antibiotic for the Treatment of Severe Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to demonstrate that daily use of topical trifarotene (CD5789) 50 microgram per gram (mcg/g) cream when used in association with oral antibiotic is safe and effective for the treatment of severe AV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trifarotene Cream + Doxycycline
Arm Type
Experimental
Arm Description
Participants were applied with Trifarotene (CD5789) 50 micrograms per gram (mcg/g) cream topically on the face once daily in the evening for 12 weeks and received doxycycline 120 milligrams (mg) tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Arm Title
Trifarotene Vehicle + Doxycycline Placebo
Arm Type
Placebo Comparator
Arm Description
Participants were applied with vehicle CD5789 topically on the face once daily in the evening for 12 weeks and received doxycycline matching placebo tablet orally once daily in the evening and 1 tablet in the morning on Day 2 of every week for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Trifarotene cream
Other Intervention Name(s)
AKLIEF
Intervention Description
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Doxycycline hyclate
Other Intervention Name(s)
DORYX MPC
Intervention Description
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Trifarotene Vehicle
Intervention Description
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Doxycycline Placebo
Intervention Description
Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Facial Total Lesion Counts to Week 12
Description
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face.
Time Frame
From Baseline to Week 12
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12
Description
All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.
Time Frame
From Baseline to Week 12
Title
Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12
Description
Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.
Time Frame
From Baseline to Week 12
Title
Percentage of Participants Who Achieved an IGA Score of 1 (Almost Clear) or 0 (Clear) and At Least a 2-Grade Improvement From Baseline to Week 12
Description
IGA was an assessment scale used to evaluate facial acne severity. IGA was recorded from components collected on the case report form (CRF) using a 5-point scale where (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on inflammation, pustules and papulation/infiltration. Success Rate was defined as the percentage of participants who achieved an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
Time Frame
From Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with clinical diagnosis of acne vulgaris, defined by IGA score of 4 (Severe) Participants with at least 20 inflammatory lesions (papules and pustules) and 30 to 120 non-inflammatory lesions (open comedones and closed comedones) and no more than 2 nodules (less than [<]1 centimeter [cm] in diameter) on the face, excluding the nose Agrees to provide written informed consent Participant is a female of non-childbearing potential (premenarchal or postmenopausal [absence of menstrual bleeding for 1 year prior to Screening, without any other medical reason], hysterectomy or bilateral oophorectomy) Exclusion Criteria: Participant with any acne cyst on the face Participants with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.) Participants with facial dermal conditions (example [e.g.] tattoo, skin abrasion, eczema, sunburned skin, scars, nevi, etc.) that may interfere with study assessments in the opinion of the investigator Participants who is at risk in terms of precautions, warnings, and contraindications for trifarotene or doxycycline hyclate Currently receiving any prescription testosterone therapy (e.g., testosterone cypionate, testosterone enanthate, testosterone pellet, testosterone undecanoate) or on a testosterone booster or prescription testosterone (e.g., dehydroepiandrosterone [DHEA], Omnadren, Sustanon, testosterone cypionate, testosterone enanthate, testosterone propionate, testosterone phenylpropionate) or testosterone supplements (e.g., Tribulus).
Facility Information:
Facility Name
Galderma Investigational Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Galderma Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Galderma Investigational Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Galderma Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Galderma Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Galderma Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Galderma Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Galderma Investigational Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Galderma Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Galderma Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Galderma Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Galderma Investigational Site
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Galderma Investigational Site
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Galderma Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Galderma Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Galderma Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Galderma Investigational Site
City
Sugarloaf
State/Province
Pennsylvania
ZIP/Postal Code
18249
Country
United States
Facility Name
Galderma Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
71913
Country
United States
Facility Name
Galderma Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Galderma Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Galderma Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Galderma Investigational Site
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Galderma Investigational Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Galderma Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Galderma Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Galderma Investigational Site
City
Aibonito
ZIP/Postal Code
705
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)

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