Journal of Clinical and Aesthetic Dermatology

AUG 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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32 JCAD journAl oF clinicAl And Aesthetic derMAtology August 2017 • Volume 10 • number 8 o r i G i n A L r e s e A r c h types i and ii. 1 0 older women often express interest in noninvasive cosmetic procedures for p hotoaged décolletage, 1 1 a nd if they are undergoing field therapy for Ak, they may ask about a treatment that can concurrently provide cosmetic improvement. 11 Although the 0.05% formulation of ingenol mebutate is the indicated formulation for use on the chest, this dose can be associated with poor tolerability. Pellacani et al 12 observed greater local skin responses (Lsr) on the chest than at other trunk and extremity sites following application of ingenol mebutate gel 0.05% to a 25cm 2 area for two consecutive days. in our practice, we also have observed poor tolerability of ingenol mebutate gel 0.05% on the chest, particularly among women. to address these issues in Ak treatment of the chest, with special consideration for the cosmetic concerns of women, we studied the effects of applying the facial formulation of ingenol mebutate gel 0.015% to a larger area of the chest, less than100 cm 2 . in addition to assessing efficacy and safety, we assessed the cosmetic effects, changes in signs of photodamage, and patient satisfaction with skin appearance. Methods study design. this was a single-center, single-arm, open-label study ( identifier nct02446223). the clinical study protocol, any amendments to the clinical study protocol, and informed consent forms were approved by the appropriate institutional review board. subjects. the study enrolled adults at least 18 years old with four or more clinically typical Aks within one contiguous area of the chest less than100cm 2 . subjects were asked to refrain from the use of topical products containing alpha-hydroxy acids, retinoic acid, retinol, salicylic acid, and vitamins c or D (or their derivatives) in the treatment area for seven days prior to and during the entire study period. Women of child-bearing potential were required to use an accepted form of birth control. subjects were excluded if hypertrophic or h yperkeratotic Ak lesions were present in the prospective treatment area or if any skin condition was present or intervention was required that might interfere with evaluation of the treatment area. other exclusion criteria were pregnancy or infant nursing, planning a pregnancy during the study period, or known hypersensitivity to, prior allergic reaction to, or previous chest treatment with ingenol mebutate gel. subjects were not enrolled if they had any dermatologic condition that might interfere with the diagnosis or evaluation of study parameters or if they had received ablative laser treatments on the chest within six months of entry or other topical therapies for Ak within three months of entry, or had received intense pulsed light treatments within 30 days of entry. Use of self-tanners or excessive exposure to sunlight or artificial UV radiation within seven days of entry was prohibited. All subjects provided written informed consent. interventions. the schedule of treatment included investigator-guided, in-office application of ingenol mebutate gel 0.015% at the first visit on Day 0 (baseline) and subjects' self-administration of ingenol mebutate gel on Days 1 and 2. six follow-up visits were scheduled on Days 1, 3, 10, 17, 24, and 59. study assessments. the primary efficacy end point was complete clearance of all clinically visible Aks at Day 59 as compared with the pretreatment lesion count. A secondary efficacy end point was stratification of subjects into groups based on percent clearance as follows: partial clearance (≥75%), mild clearance (≥10% and <75%), minimal to no clearance (<10%), worsened (observable increase in Ak), and unable to be assessed. the cosmetic eWect of ingenol mebutate gel was measured by investigator-evaluated changes in photodamage across six categories (e.g., dyschromia, erythema/telangiectasias, keratoses, texture, and rhytides), which were assessed with the modified Alexiades- Armenakas comprehensive grading scale, an 8- point grading scale (0–4, with half-numerals b etween 1 and 4, where higher numbers indicate greater severity). 13 subjects self- assessed satisfaction with skin appearance by grading improvement in signs of skin aging (e.g., rhytides, dyschromia, telangiectasias, keratosis, erythema, and overall satisfaction) with a 7-point scale (0–6), where a score of 3 was neutral, and higher numbers indicated higher satisfaction. subjects also completed the 14-item treatment satisfaction Questionnaire for medication (tsQm, version 1.4). 14 Pretreatment photography was obtained at baseline and at each follow-up visit, and safety was assessed by individual Lsr (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ ulceration), evaluated with a photographic guide and graded on a scale of 0 to 4, with higher numbers indicating greater severity. 8,15 in addition, adverse events (Ae) were recorded at each follow-up visit. statistical analysis. All statistical tests were two-sided and interpreted at a five- percent significance level. Descriptive statistics (i.e., mean, standard deviation [sD]) were provided for all continuous variables, and frequencies were provided for all categorical variables. single-factor analysis of variance (AnoVA) tests were used to track changes for individual variables across all follow-up visits, while comparisons between two individual visits were performed using two-sample t-tests assuming equal variance. P-values less than 0.05 were considered clinically significant. results study population. A total of 21 subjects (18 women; 3 men) with a mean (sD) Ak count of 11.3 (5.2) were enrolled and received treatment (table 1). efficacy. Ak clearance was assessed at Day 59 in the 20 subjects who completed the study (1 patient was lost to follow-up) (table 2). For less than complete clearance of Ak, counts at Day

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