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Clinical Trial
. 2019 May;180(5):1030-1038.
doi: 10.1111/bjd.17455. Epub 2019 Jan 8.

Efficacy and safety of PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild-to-moderate atopic dermatitis: a phase IIb randomized trial

Y W Lee  1 , C-H Won  2 , K Jung  3 , H-J Nam  3 , G Choi  3 , Y-H Park  3 , M Park  3 , B Kim  4
Affiliations
Clinical Trial

Efficacy and safety of PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild-to-moderate atopic dermatitis: a phase IIb randomized trial

Y W Lee et al. Br J Dermatol. 2019 May.

Abstract

Background: Transient receptor potential vanilloid subfamily, member 1 (TRPV1) may play an important role in pruritus and inflammation induction in atopic dermatitis (AD). The treatment effect of TRPV1 antagonist via topical application in patients with AD remains unknown.

Objectives: To assess the clinical efficacy and safety of PAC-14028, a TRPV1 antagonist, via topical application in patients with AD.

Methods: In this 8-week, phase IIb, randomized, double-blind, multicentre, vehicle-controlled study, patients with mild-to-moderate AD were randomized to receive PAC-14028 cream 0·1%, 0·3%, 1·0% or vehicle cream twice daily. The primary efficacy end point was the Investigator's Global Assessment (IGA) success rate defined as the percentage of patients with an IGA score of 0 or 1 at week 8. The secondary efficacy end points included the severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index (EASI) 75/90.

Results: A total of 194 patients were enrolled. IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (P = 0·0025 vs. vehicle), 38·30% for PAC-14028 cream 0·3% (P = 0·0087 vs. vehicle) and 57·45% for PAC-14028 cream 1·0% (P < 0·001 vs. vehicle). In particular, statistically significant differences were found between the vehicle and treatment groups in the IGA success rates with two-grade improvement. The SCORAD index, EASI 75/90, sleep disturbance score and pruritus visual analogue scale showed a trend towards improvement. No significant safety issues were reported.

Conclusions: PAC-14028 cream may be an effective and safe treatment modality for the treatment of patients with mild-to-moderate AD.

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Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Treatment success rate (%) in the Investigator's Global Assessment (IGA). (a) Percentage of patients who were assessed as 0 (clear) or 1 (almost clear) according to the week‐8 IGA score. (b) Percentage of patients who were assessed as 0 (clear) or 1 (almost clear) IGA score with two‐grade improvement from the baseline at week 1, 3, 6 and 8 (*P < 0·05 vs. vehicle, **P < 0·01 vs. vehicle, ***P < 0·001 vs. vehicle).
Figure 3
Figure 3
Efficacy analysis of severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index (EASI) score. (a) Mean change in SCORAD index from the baseline at week 1, 3, 6 and 8 (*P < 0·05 vs. vehicle). (b) Proportion of patients achieving ≥ 75% improvement from baseline in the week‐8 EASI score. (c) Proportion of patients achieving ≥ 90% improvement from baseline in the week‐8 EASI score.
Figure 4
Figure 4
Patient‐reported outcomes based on pruritus visual analogue scale (VAS) and sleep disturbance score. (a) Mean change from baseline in pruritus VAS at 1, 3, 6 and 8 weeks. (b) Mean change from baseline sleep disturbance score at 1, 3, 6 and 8 weeks (*P < 0·05 vs. vehicle, **P < 0·01 vs. vehicle, ***P < 0·001 vs. vehicle).
Figure 5
Figure 5
Clinical photographs of three patients treated with PAC‐14028 cream 1·0% (a), PAC‐14028 cream 0·3% (b), PAC‐14028 cream 0·1% (c) from baseline to week 8.
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References

    1. Nygaard U, Deleuran M, Vestergaard C. Emerging treatment options in atopic dermatitis: topical therapies. Dermatology 2017; 233:333–43. - PubMed
    1. Ring J. Atopic Dermatitis. Heidelberg: Springer International Publishing, 2016.
    1. Bieber T. Atopic dermatitis. N Engl J Med 2008; 358:1483–94. - PubMed
    1. Beattie PE, Lewis‐Jones MS. A comparative study of impairment of quality of life in children with skin disease and children with other chronic childhood diseases. Br J Dermatol 2006; 155:145–51. - PubMed
    1. Paller AS, Kabashima K, Bieber T. Therapeutic pipeline for atopic dermatitis: end of the drought? J Allergy Clin Immunol 2017; 140:633–43. - PubMed

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