Dataset Information

Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne.

ABSTRACT:

Background

Treatment for both facial and truncal acne has not sufficiently been studied.

Objectives

To evaluate the long-term safety and efficacy of trifarotene in both facial and truncal acne.

Methods

In a multicentre, open-label, 52-week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). A validated QOL questionnaire was completed by the patient at Baseline, Week 12, 26 and 52/ET.

Results

Of 453 patients enrolled, 342 (75.5%) completed the study. Trifarotene-related treatment-emergent adverse events (TEAEs) were reported in 12.6% of patients, and none was serious. Most related TEAEs were cutaneous and occurred during the first 3 months. Signs and symptoms of local tolerability were mostly mild or moderate and severe signs, and symptoms were reported for 2.2% to 7.1% of patients for the face and 2.5% to 5.4% for the trunk. Local irritation increased during the first week of treatment on the face and up to Weeks 2 to 4 on the trunk with both decreasing thereafter. At Week 12, IGA and PGA success rates were 26.6% and 38.6%, respectively. Success rates increased to 65.1% and 66.9%, respectively at Week 52. Overall success (both IGA and PGA success in the same patient) was 57.9% at Week 52. At Week 52 visit, 92/171 (53.8%) patients who had completed their assessments had scores from 0 to 1 (i.e. no effect of acne on their QOL) vs. 47/208 (22.6%) patients at Baseline visit.

Conclusion

In this 52-week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.

SUBMITTER: Blume-Peytavi U

PROVIDER: S-EPMC7004112 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne.

Blume-Peytavi U U Fowler J J Kemény L L Draelos Z Z Cook-Bolden F F Dirschka T T Eichenfield L L Graeber M M Ahmad F F Alió Saenz A A Rich P P Tanghetti E E

Journal of the European Academy of Dermatology and Venereology : JEADV 20190820 1

<h4>Background</h4>Treatment for both facial and truncal acne has not sufficiently been studied.<h4>Objectives</h4>To evaluate the long-term safety and efficacy of trifarotene in both facial and truncal acne.<h4>Methods</h4>In a multicentre, open-label, 52-week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). ...[more]

PMID: 31306527

Similar Datasets

Project description:ImportanceAcne is a common, multifactorial skin condition, and treatments with novel mechanisms have been elusive.ObjectiveTo assess the safety and efficacy of clascoterone cream, 1%, a novel topical androgen receptor inhibitor, in 2 phase 3 randomized clinical trials (CB-03-01/25 and CB-03-01/26).Design, setting, and participantsTwo identical, multicenter, randomized, vehicle-controlled, double-blind, phase 3 studies conducted from November 2015 to April 2018 evaluated the efficacy and safety of use of clascoterone cream, 1%, in males and nonpregnant females 9 years and older with moderate or severe facial acne as scored on the Investigator's Global Assessment scale. Participants were enrolled if they had 30 to 75 inflammatory lesions and 30 to 100 noninflammatory lesions.InterventionsPatients were randomized to treatment with clascoterone cream, 1%, or vehicle cream and applied approximately 1 g to the whole face twice daily for 12 weeks.Main outcomes and measuresTreatment success was defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline and absolute change from baseline in noninflammatory and inflammatory lesion counts at week 12. Safety measures included adverse event frequency and severity.ResultsA total of 1440 patients were randomzied in 2 studies. In CB-03-01/25, 353 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-58] years; 221 [62.6%] female), and 355 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [9-50] years; 215 (60.6%) female); in CB-03-01/26, 369 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-50] years; 243 [65.9%] female), and 363 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [range, 11-42] years; 221 [60.9%] female). At week 12, treatment success rates in CB-03-01/25 and CB-03-01/26 with clascoterone cream, 1%, were 18.4% (point estimate, 2.3; 95% CI, 1.4-3.8; P < .001) and 20.3% (point estimate, 3.7; 95% CI, 2.2-6.3; P < .001) vs 9.0% and 6.5% with vehicle, respectively. At week 12, in both CB-03-01/25 and CB-03-01/26, treatment with clascoterone cream, 1%, resulted in a significant reduction in absolute noninflammatory lesions from baseline to -19.4 (point estimate difference, -6.4; 95% CI, -10.3 to -2.6; P < .001) and -19.4 (point estimate difference, -8.6; 95% CI, -12.3 to -4.9; P < .001) vs -13.0 and -10.8 with vehicle, respectively, as well as a reduction in inflammatory lesions from baseline to -19.3 (point estimate difference, -3.8; 95% CI, -6.4 to -1.3; P < .001) and -20.0 (point estimate difference, -7.4; 95% CI, -9.8 to -5.1; P < .001) vs -15.5 and -12.6 with vehicle, respectively. Adverse events rates were low and mostly mild; the predominant local skin reaction was trace or mild erythema.Conclusions and relevanceUse of clascoterone cream, 1%, for acne treatment appears to demonstrate favorable efficacy and safety with low adverse event rates.Trial registrationClinicalTrials.gov Identifiers: NCT02608450 and NCT02608476.

Project description:IntroductionHalf of the individuals with facial acne develop truncal acne, but the impact of combined facial and truncal acne (CA) on patients' quality of life is poorly researched.MethodsA 60-min interview of 30 participants with CA was conducted that formed the basis for a cross-sectional survey of 694 adolescents and adults with CA.ResultsThe main themes identified from the qualitative interviews among CA subjects included acceptability to self and others, social functioning and emotional wellbeing. Feelings of embarrassment, self-consciousness and low confidence were experienced often or all the time by over 50% of participants, and were more frequent in those who perceived their acne to be out of control (P = 0.003). Half of patients reported feeling stigmatised because of their CA, and 65.4% believed that others associated their truncal acne with unhealthy or unhygienic habits. Perceived stigma was associated with more feelings of embarrassment (P = 0.005), self-consciousness (P = 0.034) and low self-confidence (P = 0.017). Overall, 64% participants reported that CA interfered with daily life, 46.4% often or always avoided social interaction, 48.6% were often concerned about talking to unfamiliar people and 47.4% were uncomfortable showing affection. Further, 32% and 24.4% participants ≥ 16 years old avoided dating or having romantic/intimate relationships because of their facial and truncal acne, respectively. Social and leisure activities were more frequently negatively impacted among those with perceived uncontrolled CA than among those with controlled CA. Avoiding undressing in front of spouse/partner/friends/relatives was more commonly reported by participants with perceived uncontrolled truncal acne than by those with controlled truncal acne (90.5% versus 80.6%, P = 0.031).ConclusionCA is associated with considerable psychological morbidity, with several exacerbating (e.g. perceived stigma) and attenuating factors (e.g. acne being perceived as being under control) that should be accounted for in CA management.

Dataset Information

Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne.

Background

Objectives

Methods

Results

Conclusion

Publications

Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets