Facial acne Skin and Connective Tissue Diseases Acne
Conditions
Interventions
1. ANW vs placebo
2. Two daily treatments (morning and evening for 12 consecutive weeks
3. Each daily treatment consists in spraying the product on the skin affected by acne (13 times of 100ul each to
Sponsors
Applied Pharma Research (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients with acne 2. Above age 18 3. Able to comply with the study procedures, in the opinion of the investigator, and able to give a voluntary written informed consent for participation in the trial 4. Diagnosis of severity of facial acne either 2 or 3 grade according to the Investigator?s Global Assessment (IGA) scale 5. The patient can exclude to become pregnant during the study
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Breastfeeding 3. More than one nodulo-cystic lesion per side of the face 4. Subject with facial acne who used any topical treatment in the last 7 days, and/or systemic antibiotic therapy in the last 30 days and/or systemic retinoid in the last six months 5. Cancer or history of cancer 6. Significant history of hematologic, cardiovascular, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease 7. Reported HIV infection 8. Known or suspected individual hypersensitivity to any component of the product 9. Use of hormonal contraceptives, stilbestrol/ d.e.s., primidone, fluoxetine, phenylpropanolamine, methylphenidate, troglitazone, gemfibrozil, cerivastatin, isotretinoin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The present pilot study will assess the efficacy and safety of ANW solution in the treatment of facial acne 2. Both the assessment of the IGA and the number of inflammatory (mainly papules and pustules) and non inflammatory (mainly comedones) lesions will serve as primary end-points for quantifying treatment efficacy, to be assessed at each planned visit, including the first (recruitment) visit 3. Non-inflammatory lesions (open -blackheads- or closed -white heads- comedones), are not expected to be affected by ANW treatment 4. Nevertheless, they will be counted in order to evaluate whether there is any effect on this parameter, either curative or comedogenic 5. The safety of the product will be monitored during the whole study by reporting all the Adverse Events in the CRF, diary | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjects who will provide specific consent will be photographed by a standardized method, using high-resolution digital photography 2. In any case photos will be taken with a framing and/or post-acquisition elaboration preventing recognition of the photographed subject 3. A nine-score grading of acne severity will be performed by the Investigator according to his/her clinical judgement at each visit starting from scheduled visit 2 4. This assessment will considered modification of the clinical severity in comparison with the previous scheduled visit, in accordance to the following qualitative evaluation (as reported in proper CRF) 5. Each subject is invited to report daily in the diary his/her subjective evaluation regarding the treatment 6. Furthermore, a standardized questionnaire on Quality of Life assessment in subjects affected by facial acne (Acne-QoL) will be appended to the diary for self-administration at two visits, namely at study entry and after the 12-week treatment period (scheduled visit number 5) 7. The 19 questions of Acne-QoL are framed to be specific to site (??... because of your facial acne??) and time (??... in the past week?) 8. The measurement of psychosocial impact of disease has, until recently, been a relatively neglected component of the clinical paradigm 9. In acne, increasing recognition that objective clinical measures may be inadequate in assessing the overall impact and effect of this disease has led to the development of disease-specific psychometric instruments 10. The Acne-QoL questionnaire was developed specifically to assess health-related quality of life for clinical trials in acne and has been widely validated in several clinical studies | — |
Countries
Italy
Outcome results
None listed