Status:
COMPLETED
The Effect of Skin Cleansers on the Skin Surface Microbiome
Lead Sponsor:
Mundipharma Manufacturing Pte Ltd.
Collaborating Sponsors:
Genome Institute of Singapore
Conditions:
Skin Health
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief Summary
This study determines the effects of a single application of different antiseptic skin cleansers on the composition of the skin surface microbiome using next-generation sequencing (NGS) techniques. Tw...
Detailed Description
Disinfectants and oral antiseptics including PVP-I are known to kill microorganisms to a variable extent, at a variable range of time points. Microorganisms may be protected from disinfectants by prod...
Eligibility Criteria
Inclusion
- Male and female subjects between age 21 to 65 years
- Must wear short sleeved shirts/blouses during each visit
- Non-smoker
- Good general and mental health with, in the opinion of investigator or the qualified medical designee:
- No clinically significant and relevant abnormalities of medical history or physical examination;
- Absence of any condition that would impact the subject's safety or health or affect the subject's ability to understand and comply with the study procedures.
- Prepared to use the provided wash products that do not contain any antimicrobials (non antibacterial shampoo \[Pantene® Pro-V\], non antibacterial body wash \[Dove®body wash\] and non antibacterial hand wash \[Guardian gel hand wash\]) after providing consent and during the whole study
- Healthy and intact skin in the test area (e.g., no skin allergy, visible bleeding, skin inflammation, skin ulcer or skin lesion, no need for cutaneous treatment)
- Must have given written informed consent
- Women of child-bearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Exclusion
- Women who are pregnant or have a positive urine pregnancy test or intending to become pregnant during the overall study period
- Women who are breast-feeding
- Allergy or contraindication to any test product substance (active or excipients)
- Any visible signs of skin dermatitis on the hands, e.g., eczema
- Use of anti-dandruff shampoo or any other shampoo/hand/body wash products apart from those provided, within 2 days prior to Visit 2 (Day 0) and also during the whole study
- Systemic or topical or oral antibiotic or antifungal in the past 2 months before Screening and during the study
- Medication use (e.g., lithium therapy, immunosuppressive medication, systemic or inhaled glucocorticoids) in the past 2 months before Screening and during the study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- Known hyperthyroidism or other ongoing thyroid diseases
- Minor ailments such as like cough, cold, upper respiratory tract infection(s) within 2 weeks and during the study
- Any known serious ongoing disease
- Unwillingness or inability to comply with the requirements of the protocol
- Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) before Screening
- An employee of the sponsor or study site or their immediate family member
- Subject who has been treated with cancer within the last 1 year.
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03348917
Start Date
December 28 2017
End Date
January 26 2018
Last Update
February 28 2018
Active Locations (1)
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1
National University Hospital Singapore
Singapore, Singapore, 119074