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Completed

NCT Number: NCT04451330

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Galderma Investigational Site, Aibonito, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Trifarotene Cream

Drug

Trifarotene 50 mcg/g cream applied topically once daily on face for 12 weeks.

Other names: AKLIEF

Doxycycline Hyclate

Drug

Doxycycline hyclate delayed release 120 mg tablets was administered orally for 12 weeks.

Other names: DORYX MPC

Trifarotene Vehicle

Drug

Trifarotene 50 mcg/g vehicle cream was applied topically once daily on face for 12 weeks.

Doxycycline Placebo

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Acronym: DUAL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2020
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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