Topical corticosteroid has no influence on inflammation or efficacy after ingenol mebutate treatment of grade i to III actinic keratoses (AK): A randomized clinical trial

TY - JOUR

T1 - Topical corticosteroid has no influence on inflammation or efficacy after ingenol mebutate treatment of grade i to III actinic keratoses (AK)

T2 - A randomized clinical trial

AU - Erlendsson, Andrés Már

AU - Karmisholt, Katrine Elisabeth

AU - Skovbølling Haak, Christina

AU - Stender, Ida-Marie

AU - Haedersdal, Merete

PY - 2016/4

Y1 - 2016/4

N2 - Background Ingenol mebutate (IngMeb) is approved for treatment of actinic keratoses (AK) and may cause unpredictable local skin responses (LSR). Objectives We sought to investigate whether IngMeb-induced LSR, pain, and pruritus could be alleviated with a topical glucocorticoid and, further, to assess efficacy, cosmetic outcome, and patient satisfaction in patients with severe photodamage. Methods In this blinded, randomized controlled clinical trial, patients with multiple AK and field cancerization of the face or scalp were treated in 2 areas with IngMeb (0.015%) daily for 3 days. After finalized IngMeb treatment, 1 area was randomized to receive topical clobetasol propionate (0.05%) twice daily for 4 days. Assessments included LSR (0-24; days 1, 4, 8, 15, 57), pain (0-10) and pruritus (0-3; days 1-15), AK clearance (days 15, 57), and cosmetic outcome (0-3; day 57). Results Clobetasol propionate application had no influence on LSR (P =.939), pain (P =.500), pruritus (P =.312), or AK cure rate (P =.991). Overall, IngMeb cleared 86% of all AK lesions, exerting a therapeutic effect on all AK severity grades; cure rates were 88%, 70%, and 60% for grade I, II, and III AK, respectively. Skin texture improved significantly in remedied areas (2.0 vs 1.0; P <.001); no hypopigmentation, hyperpigmentation, or scarring were observed. Limitations These results do not provide safety and efficacy beyond 2 months of follow-up. Conclusion Application of clobetasol propionate does not alleviate IngMeb-induced LSR after 3 days of IngMeb treatment.

AB - Background Ingenol mebutate (IngMeb) is approved for treatment of actinic keratoses (AK) and may cause unpredictable local skin responses (LSR). Objectives We sought to investigate whether IngMeb-induced LSR, pain, and pruritus could be alleviated with a topical glucocorticoid and, further, to assess efficacy, cosmetic outcome, and patient satisfaction in patients with severe photodamage. Methods In this blinded, randomized controlled clinical trial, patients with multiple AK and field cancerization of the face or scalp were treated in 2 areas with IngMeb (0.015%) daily for 3 days. After finalized IngMeb treatment, 1 area was randomized to receive topical clobetasol propionate (0.05%) twice daily for 4 days. Assessments included LSR (0-24; days 1, 4, 8, 15, 57), pain (0-10) and pruritus (0-3; days 1-15), AK clearance (days 15, 57), and cosmetic outcome (0-3; day 57). Results Clobetasol propionate application had no influence on LSR (P =.939), pain (P =.500), pruritus (P =.312), or AK cure rate (P =.991). Overall, IngMeb cleared 86% of all AK lesions, exerting a therapeutic effect on all AK severity grades; cure rates were 88%, 70%, and 60% for grade I, II, and III AK, respectively. Skin texture improved significantly in remedied areas (2.0 vs 1.0; P <.001); no hypopigmentation, hyperpigmentation, or scarring were observed. Limitations These results do not provide safety and efficacy beyond 2 months of follow-up. Conclusion Application of clobetasol propionate does not alleviate IngMeb-induced LSR after 3 days of IngMeb treatment.

KW - actinic keratoses

KW - actinic keratosis

KW - blinded

KW - clearance

KW - clobetasol

KW - corticosteroid

KW - cosmesis

KW - cosmetic outcome

KW - cure rate

KW - glucocorticoid

KW - hyperkeratotic

KW - inflammation

KW - ingenol mebutate

KW - local skin responses

KW - pain

KW - patient satisfaction

KW - photodamage

KW - pruritus

KW - rejuvenation

KW - skin texture

U2 - 10.1016/j.jaad.2015.11.034

DO - 10.1016/j.jaad.2015.11.034

M3 - Journal article

C2 - 26810403

AN - SCOPUS:84960357016

SN - 0190-9622

VL - 74

SP - 709

EP - 715

JO - American Academy of Dermatology. Journal

JF - American Academy of Dermatology. Journal

IS - 4

ER -