Skin Health Clinical Trial
Official title:
The Effect of Skin Cleansers on the Skin Surface Microbiome
Verified date | February 2018 |
Source | Mundipharma Manufacturing Pte Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 26, 2018 |
Est. primary completion date | January 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
Mundipharma Manufacturing Pte Ltd. | Genome Institute of Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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)] | |
Primary | 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)] | |
Primary | 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)] | |
Primary | 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)] |
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