pep005 and Erythema

Topics: Antineoplastic Agents; Cryosurgery; Diterpenes; Erythema; Humans; Image Processing, Computer-Assisted; Keratosis, Actinic; Photography; Software

Anogenital warts (AGW) can cause physical discomfort and decreased quality of life. Recent case reports suggest that ingenol mebutate gel might be an effective treatment of AGW.. To explore primarily the safety, and secondarily the efficacy of ingenol mebutate gel 0.05% in patients with AGW.. This was an exploratory, open-label, 1-arm trial of ingenol mebutate gel 0.05% administered up to three times to patients with AGW. Safety was assessed by occurrence and severity of local skin reactions (LSRs) and treatment-related adverse events (AEs). Efficacy was assessed by complete clearance and reduction in AGW count 14 days after last treatment, and recurrence 12 weeks after clearance.. Of 41 patients enrolled, 40 received treatment and 26 completed the trial. Patients had a median AGW count of 11.0 and AGW duration of 3.0 years at baseline. All patients experienced transient LSRs following treatment with a maximum composite LSR score of 7.5 (on a scale from 0 to 18). A total of 93% of patients reported treatment-related AEs, most frequently pain (85%) and procedural complications (35%) due to smearing of the gel. 78% of patients took mild analgesics for the pain, typically for 1-2 days following treatment. The majority of AEs were of moderate-to-severe intensity. Seventeen of 39 patients (43.6%) had complete clearance 14 days after last treatment, and AGW count was reduced by 90.9%. There was a tendency towards lower clearance rate in patients with longer duration of AGW. Eight of 14 patients (57.1%) had AGW recurrence 12 weeks after clearance.. Ingenol mebutate gel was associated with a high number of AEs and withdrawals due to painful local and adjacent skin reactions. Furthermore, it showed promising efficacy in reducing AGW despite a difficult-to-treat population. Optimization of the formulation is warranted to improve the safety profile of the treatment.

Topics: Adult; Aged; Antineoplastic Agents; Anus Diseases; Blister; Condylomata Acuminata; Diterpenes; Edema; Erythema; Female; Gels; Genital Diseases, Female; Genital Diseases, Male; Humans; Male; Middle Aged; Pain; Prospective Studies; Recurrence; Skin Ulcer; Treatment Outcome; Young Adult

Ingenol mebutate (IngMeb) 0.015% gel is an approved field treatment option for non-hyperkeratotic non-hypertrophic actinic keratosis (AK) of face and scalp. Efficacy of IngMeb has been assessed only on a clinical ground, in the majority of studies. Dermoscopy is a pivotal tool for the diagnosis of AK, while its role in evaluating the response to non-surgical therapies for AK has not been fully defined.. Our study aims to determine whether some dermoscopic features of AK of the face and scalp areas may independently predict the response to IngMeb therapy.. Clinical and dermoscopic responses, 1 month after 0.015% IngMeb therapy, were retrospectively evaluated using a per-patient and per-lesion approach. Safety was evaluated through local skin reaction composite score calculation. Demographic, clinical and dermoscopic factors were then evaluated via univariate and multivariate logistic regression analysis to assess independent predictors of response.. Fifty-five patients with 245 AKs were enrolled. Clinically, per-patient response evaluation identified 25 (45.4%) poor/partial and 30 (54.5%) complete responders, corresponding on a per-lesion approach to 66 (26.9%) and 179 (73.1%) AKs, respectively. Dermoscopy reclassified 14 patients in the per-patient and 48 AKs in the per-lesion analysis from complete to poor/partial responders. Multivariate logistic regression analysis showed that AKs dermoscopically characterized by red pseudonetwork and located on the face were independently associated with a complete dermoscopic response to 0.015% IngMeb therapy, while microerosions were negative predictors.. Specific dermoscopic features of AK may predict the response to 0.015% IngMeb therapy, together with the location on the face.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Antineoplastic Agents; Dermoscopy; Diterpenes; Erythema; Facial Dermatoses; Female; Gels; Humans; Keratosis, Actinic; Male; Predictive Value of Tests; Retrospective Studies; Scalp Dermatoses; Treatment Outcome

Topics: Administration, Topical; Aged; Aged, 80 and over; Disease Management; Diterpenes; Erythema; Female; Follow-Up Studies; Humans; Keratosis, Actinic; Male; Skin