The Effect of Skin Cleansers on the Skin Surface Microbiome

NCT03348917 | Completed Phase 4

• 1 other identifier: BTD16-SG-402
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Health

Outcome Measures

Primary Outcomes (4)

• Composition of skin microbiome - reduction of microflora amount

  The change in amount of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.

  [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]

• Composition of skin microbiome - maintenance of healthy microflora amount

  The change in amount of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.

  [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]

• Composition of skin microbiome - reduction of microflora variety

  The change in variety of skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.

  [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]

• Composition of skin microbiome - maintenance of healthy microflora variety

  The change in variety of healthy skin microflora species composition from baseline after the usage of a single application of different skin cleansers using next generation sequencing (NGS) and real-time PCR techniques at 3 mins and 240 mins.

  [Time Frame: Skin Strip 1: 0 Min, Skin Strip 2: 3 min (post treatment) and Skin Strip 3: 240 min (post treatment)]

Study Arms (3)

Treatment sequence Group 1

ACTIVE COMPARATOR

Treatment Sequence Group 1 = A -\> B -\> C Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%) Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated)

Drug: 7.5% Povidone-Iodine [PVP-I]; Drug: 4% chlorhexidine skin cleanser; Drug: Plain non antibacterial soap

Treatment sequence Group 2

ACTIVE COMPARATOR

Treatment Sequence Group 2 = B -\> C -\> A Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol) Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated) Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%)

Drug: 7.5% Povidone-Iodine [PVP-I]; Drug: 4% chlorhexidine skin cleanser; Drug: Plain non antibacterial soap

Treatment sequence Group 3

ACTIVE COMPARATOR

Treatment Sequence Group 3 = C -\> A -\>B Treatment C = Plain non antibacterial soap - Guardian gel hand wash (not medicated) Treatment A = Betadine® 7.5% skin cleanser (PVP-I 7.5%) Treatment B = 4% chlorhexidine skin cleanser - Unity antiseptic hand wash (no alcohol)

Drug: 7.5% Povidone-Iodine [PVP-I]; Drug: 4% chlorhexidine skin cleanser; Drug: Plain non antibacterial soap

Interventions

7.5% Povidone-Iodine [PVP-I] DRUG

Betadine® 7.5% skin cleanser (PVP-I 7.5%)

Treatment sequence Group 1; Treatment sequence Group 2; Treatment sequence Group 3

4% chlorhexidine skin cleanser DRUG

Unity antiseptic hand wash (no alcohol)

Treatment sequence Group 1; Treatment sequence Group 2; Treatment sequence Group 3

Plain non antibacterial soap DRUG

Guardian gel hand wash (not medicated),

Treatment sequence Group 1; Treatment sequence Group 2; Treatment sequence Group 3

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Manufacturing Pte Ltd.: lead
• Genome Institute of Singapore: collaborator

Study Sites (1)

National University Hospital Singapore

Singapore, 119074, Singapore

Location

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Nisha Su Yien Subash Chandran

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Twelve healthy volunteers will be randomized into three arms with three different treatment sequences with four healthy volunteers in each arm. Up to fifteen healthy volunteers may be recruited with the consideration that up to three subjects may drop out.

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 21, 2017
• Study Start: December 28, 2017
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)