NCT03365934

Brief Summary

This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

November 20, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 4, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

November 16, 2017

Results QC Date

February 11, 2019

Last Update Submit

May 14, 2019

Conditions

Healthy Volunteers

Keywords

MicrofloraMicrobiomeskin physiologyFitzpatrick Skin Types I-IIITape-stripped wounds

Outcome Measures

Primary Outcomes (27)

  • Microbial Community Richness - Baseline (Day 0)

    Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.

    Baseline (Day 0)

  • Microbial Community Richness - (Day 1)

    Swabs will be collected on the back at Day 1 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.

    Day 1

  • Microbial Community Richness - (Day 2)

    Swabs will be collected on the back at Day 2 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.

    Day 2

  • Microbial Community Richness - (Day 3)

    Swabs will be collected on the back at Day 3 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.

    Day 3

  • Microbial Community Richness - (Day 4)

    Swabs will be collected on the back at Day 4 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.

    Day 4

  • Microbial Community Richness - (Day 5)

    Swabs will be collected on the back at Day 5 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.

    Day 5

  • Microbial Community Richness - (Day 6)

    Swabs will be collected on the back at Day 6 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.

    Day 6

  • Microbial Community Richness - (Day 7)

    Swabs will be collected on the back at Day 7 and analyzed to determine the total number of different bacteria Taxa (microorganismss) detected in the sample.

    Day 7

  • Microbial Community Richness - (Day 14)

    Swabs will be collected on the back at Day 14 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.

    Day 14

  • Microbial Community Diversity - Baseline (Day 0)

    Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.

    Baseline (Day 0)

  • Microbial Community Diversity - Day 1

    Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.

    Day 1

  • Microbial Community Diversity - Day 2

    Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.

    Day 2

  • Microbial Community Diversity - Day 3

    Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.

    Day 3

  • Microbial Community Diversity - Day 4

    Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.

    Day 4

  • Microbial Community Diversity - Day 5

    Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.

    Day 5

  • Microbial Community Diversity - Day 6

    Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.

    Day 6

  • Microbial Community Diversity - Day 7

    Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.

    Day 7

  • Microbial Community Diversity - Day 14

    Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.

    Day 14

  • Microbial Community Evenness - Baseline (Day 0)

    Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.

    Day 0

  • Microbial Community Evenness - Day 1

    Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.

    Day 1

  • Microbial Community Evenness - Day 2

    Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.

    Day 2

  • Microbial Community Evenness - Day 3

    Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.

    Day 3

  • Microbial Community Evenness - Day 4

    Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.

    Day 4

  • Microbial Community Evenness - Day 5

    Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.

    Day 5

  • Microbial Community Evenness - Day 6

    Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.

    Day 6

  • Microbial Community Evenness - Day 7

    Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.

    Day 7

  • Microbial Community Evenness - Day 14

    Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.

    Day 14

Secondary Outcomes (18)

  • Skin Barrier Function -Baseline (Day 0)

    Day 0

  • Skin Barrier Function - Day 1

    Day 1

  • Skin Barrier Function - Day 2

    Day 2

  • Skin Barrier Function - Day 3

    Day 3

  • Skin Barrier Function - Day 4

    Day 4

  • +13 more secondary outcomes

Study Arms (6)

ADHESIVE BANDAGE #1

EXPERIMENTAL

bandage applied to wounded site.

Device: ADHESIVE BANDAGE #1

ADHESIVE BANDAGE #2

EXPERIMENTAL

bandage applied to wounded site.

Device: ADHESIVE BANDAGE #2

ADHESIVE BANDAGE #3

EXPERIMENTAL

bandage applied to wounded site

Device: ADHESIVE BANDAGE #3

Antibacterial Bandage with 0.8% BZK

EXPERIMENTAL

bandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site

Device: Antibacterial Bandage with 0.8% BZK

Intact and No Bandage

OTHER

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

Other: Intact and No Bandage

Wounded and No Bandage

OTHER

This test site will be wounded and no bandage applied, serving as a positive control site.

Other: Wounded and No Bandage

Interventions

ADHESIVE BANDAGE #1DEVICE

Bandage applied daily to wounded site for 14 days

ADHESIVE BANDAGE #1
ADHESIVE BANDAGE #2DEVICE

Bandage applied daily to wounded site for 14 days

ADHESIVE BANDAGE #2
ADHESIVE BANDAGE #3DEVICE

Bandage applied daily to wounded site for 14 days

ADHESIVE BANDAGE #3
Antibacterial Bandage with 0.8% BZKDEVICE

bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days

Antibacterial Bandage with 0.8% BZK
Intact and No BandageOTHER

This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.

Intact and No Bandage
Wounded and No BandageOTHER

This test site will be wounded but will not be treated with a bandage, serving as the positive control site.

Wounded and No Bandage

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18 to 55 years of age.
  • Fitzpatrick skin types I to III.
  • Must be able to comprehend and follow the requirements of the study
  • Avoid excessive sun exposure
  • Willing to refrain from topical product use on the back for the duration of the study.
  • Subjects must agree not to immerse their bandages in water for the duration of the study.
  • Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control

You may not qualify if:

  • Excessively hairy back, acne, scars and pigmentation or nevi t
  • Pregnant or Lactating, or planning on becoming pregnant;
  • Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
  • Participation in any other clinical study within 30 days of Visit 1;
  • Subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections
  • Subjects who report using prescription or OTC medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.)
  • Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process
  • Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation
  • Subjects with a known history of keloid or hypertrophic scar formation;
  • Subjects diagnosed with any blood clotting disorder;
  • Hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 Subjects taking oral Vitamin A derivatives such as Accutane, isotretinon, or using retinoic acid in the past 1 year or using topical Vitamin A derivatives in the 3 weeks prior to study start;
  • \. Subjects with clinically infected skin lesions; 15. Subjects with cracked or excoriated skin, or other skin problems. 16. Diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control); 17. Subjects with friable skin, at the discretion of the Investigator;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TKL Research Inc.

Fair Lawn, New Jersey, 07410, United States

Location

Results Point of Contact

Title
Amisha Parikh-Das
Organization
JNJWorldwide
aparikh1@its.jnj.com
973-255-8701

Study Officials

  • Philip Lastella, MD

    TKL Research, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

December 8, 2017

Study Start

November 20, 2017

Primary Completion

February 12, 2018

Study Completion

February 12, 2018

Last Updated

June 4, 2019

Results First Posted

June 4, 2019

Record last verified: 2019-05

Locations

US(1)