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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451330
Recruitment Status : Completed
First Posted : June 30, 2020
Results First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Trifarotene cream Drug: Doxycycline hyclate Drug: Trifarotene Vehicle Drug: Doxycycline Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 29, 2020
Actual Primary Completion Date : April 26, 2021
Actual Study Completion Date : April 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Antibiotics

Arm Intervention/treatment
Experimental: Trifarotene Cream + Doxycycline
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.
Drug: Trifarotene cream
Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.
Other Name: AKLIEF

Drug: Doxycycline hyclate
Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.
Other Name: DORYX MPC

Placebo Comparator: Trifarotene Vehicle + Doxycycline Placebo
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.
Drug: Trifarotene Vehicle
Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.

Drug: Doxycycline Placebo
Doxycycline hyclate delayed release 120 mg placebo tablets was administered orally for 12 weeks.




Primary Outcome Measures :
  1. Absolute Change From Baseline in Facial Total Lesion Counts to Week 12 [ Time Frame: From Baseline 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 :
  1. Absolute Change From Baseline in Facial Inflammatory Lesions (IL) Counts to Week 12 [ Time Frame: From Baseline to Week 12 ]
    All inflammatory lesions (papules, pustules, and nodular lesions) were counted by investigator/subinvestigator.

  2. Absolute Change From Baseline in Facial Non Inflammatory Lesions (NIL) Counts to Week 12 [ Time Frame: From Baseline to Week 12 ]
    Non-inflammatory lesions (open and closed comedo) were counted by investigator/subinvestigator.

  3. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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): NCT04451330


Locations
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United States, Arkansas
Galderma Investigational Site
Fort Smith, Arkansas, United States, 72916
Galderma Investigational Site
Hot Springs, Arkansas, United States, 71913
Galderma Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Galderma Investigational Site
Newport Beach, California, United States, 92663
United States, Florida
Galderma Investigational Site
Aventura, Florida, United States, 33180
Galderma Investigational Site
Boca Raton, Florida, United States, 33486
Galderma Investigational Site
Miramar, Florida, United States, 33027
United States, Georgia
Galderma Investigational Site
Newnan, Georgia, United States, 30263
United States, Indiana
Galderma Investigational Site
Evansville, Indiana, United States, 47715
Galderma Investigational Site
New Albany, Indiana, United States, 47150
United States, Maryland
Galderma Investigational Site
Rockville, Maryland, United States, 20850
United States, Michigan
Galderma Investigational Site
Warren, Michigan, United States, 48088
United States, Minnesota
Galderma Investigational Site
New Brighton, Minnesota, United States, 55112
United States, Nevada
Galderma Investigational Site
Las Vegas, Nevada, United States, 89148
United States, New York
Galderma Investigational Site
Stony Brook, New York, United States, 11790
United States, North Carolina
Galderma Investigational Site
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Galderma Investigational Site
Sugarloaf, Pennsylvania, United States, 18249
United States, South Carolina
Galderma Investigational Site
Charleston, South Carolina, United States, 71913
United States, Tennessee
Galderma Investigational Site
Knoxville, Tennessee, United States, 37922
United States, Texas
Galderma Investigational Site
Arlington, Texas, United States, 76011
Galderma Investigational Site
Dallas, Texas, United States, 75246
Galderma Investigational Site
Grapevine, Texas, United States, 76051
Galderma Investigational Site
Pflugerville, Texas, United States, 78660
Galderma Investigational Site
San Antonio, Texas, United States, 78218
Galderma Investigational Site
San Antonio, Texas, United States, 78249
Puerto Rico
Galderma Investigational Site
Aibonito, Puerto Rico, 705
Sponsors and Collaborators
Galderma R&D
  Study Documents (Full-Text)

Documents provided by Galderma R&D:
Study Protocol  [PDF] August 21, 2020
Statistical Analysis Plan  [PDF] May 6, 2021

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT04451330    
Other Study ID Numbers: RD.06.SPR.202394
First Posted: June 30, 2020    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: May 10, 2022
Last Verified: April 2021

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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
Doxycycline
Trifarotene
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic Agents