pep005 and Edema

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

Sequential treatment of actinic keratosis (AK) and cancerization field with cryotherapy and ingenol mebutate (IM) is widely used in clinical practice, however, the order of application of sequential treatment has not been examined yet.. To compare different sequential treatments of IM and cryotherapy in AK and to monitor cure rates and local skin reactions (LSR) through reflectance confocal microscopy (RCM).. Patients with AK were treated with IM and cryotherapy. Group A received treatment with IM before cryotherapy, and group B patients were firstly treated with cryotherapy and secondly IM. RCM evaluation of epidermal dysplasia and LSR was performed prior to the first treatment (Week 0), before the second treatment (Week 2), and one month and two months after initial assessment.. The study included 26 patients - 14 patients in group A and 12 patients in group B. In both groups, significant improvement in epidermal dysplasia RCM parameters between the first and last visit was observed. Regarding LSR parameters, group A presented fewer LSR parameters than group B on the second visit. This difference was present even if comparison was made between the third visit of group A and the second visit of group B.. Both sequences of treatment are effective, but IM treatment before cryotherapy is recommended because of the lower LSR. This probably decreases patient discomfort and improves compliance.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Apoptosis; Combined Modality Therapy; Cryotherapy; Dermatitis; Diterpenes; Edema; Female; Humans; Keratosis, Actinic; Male; Microscopy, Confocal; Middle Aged; Prospective Studies