Evaluation of the efficacy of treatment with ANW for facial acne
| ISRCTN | ISRCTN75516184 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75516184 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/07/2011
- Registration date
- 16/08/2011
- Last edited
- 13/04/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Acne is a common skin condition that causes spots, oily skin and sometimes skin that's hot or painful to touch, and often develops on the face. The aim of this study is to test the effectiveness and safety of ANW as a medical device for the treatment of facial acne.
Who can participate?
Patients aged over 18 with facial acne
What does the study involve?
Participants are randomly allocated to be treated with either the ANW solution or purified water (placebo/dummy drug). The treatments are sprayed on the face twice daily for 12 weeks. No other skin treatment for acne is allowed, except the ones agreed with the researcher at the start of the study.
Assessments are carried out after 2, 4, 8, 12 and 16 weeks for follow up of effectiveness and safety.
What are the possible benefits and risks of participating?
Results obtained with equivalent devices indicate that ANW may be effective in the treatment of acne. No side effects are expected from the use of this device.
Where is the study run from?
San Raffaele Scientific Institute (Italy)
When is study starting and how long is it expected to run for?
March 2011 to May 2012
Who is funding the study?
Applied Pharma Research (Switzerland)
Who is the main contact?
Prof. Santo Raffaele Mercuri
Contact information
Scientific
Dermatology Unit
San Raffaele Scientific Institute and San Raffaele University Medical School Vita-Salute
via Olgettina, 60
Milano
20132
Italy
Study information
| Study design | Double-blind randomized monocentric placebo-controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the sponser details to request a patient information sheet |
| Scientific title | Evaluation of the efficacy of treatment with ANW for facial acne |
| Study acronym | ACNE_ANW |
| Study objectives | The hypothesis is that ANW works better than placebo in the treatment of facial acne (degree 2-3 of IGA scale) |
| Ethics approval(s) | Il Comitato Ethico Della Fondazione Centro San Raffaele del Monte Tabor Istituto Scientifio Ospedale San Raffaele - Milanom, 09/09/2010 |
| Health condition(s) or problem(s) studied | Facial acne |
| Intervention | 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 cover the entire face) and let it dry for at least 2 minutes, then in repeating the operation and let it dry again for at least 2 minutes |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 08/03/2011 |
| Completion date | 31/05/2012 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 Investigators Global Assessment (IGA) scale 5. The patient can exclude to become pregnant during the study |
| Key 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 |
| Date of first enrolment | 08/03/2011 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
20132
Italy
Sponsor information
Industry
via Corti 5
Balerna
CH-6828
Switzerland
| Website | http://www.apr.ch/site/index.html |
|---|---|
"ROR" |
https://ror.org/05c2q0q08 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
13/04/2017: Plain English summary added.
12/09/2012: Please note that this trial was stopped in September 2012 due to a lack of participants.
