The Effect of Skin Cleansers on the Skin Surface Microbiome

• Status: Completed
• Trial end date: 2018-01-26
• Target enrollment: 0
• Participant gender: All

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. Twelve healthy volunteers will receive all three test products in a randomized order to compare the effects of each skin cleanser.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mundipharma Manufacturing Pte Ltd.
• Collaborator: Genome Institute of Singapore
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Povidone; Povidone-Iodine

Criteria

Inclusion Criteria:

• 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:

1. No clinically significant and relevant abnormalities of medical history or physical examination;

2. 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 Criteria:

• 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.