To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test

NCT03233009 | Completed Results

• 1 other identifier: 207235
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (6)

• Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal

  Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.

  At Day 2 (15-30 minutes post patch removal)

• Frequency of Dermal Response Score at 24 Hours Post Patch Removal

  Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.

  At Day 3 (24 hours post patch removal)

• Frequency of Dermal Response Score at 48 Hours Post Patch Removal

  Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.

  At Day 4 (48 hours post patch removal)

• Average Dermal Response Score at 30 Minutes Post Patch Removal

  Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.

  At Day 2 (15-30 minutes post patch removal)

• Average Dermal Response Score at 24 Hours Post Patch Removal

  Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.

  At Day 3 (24 hours post patch removal)

• Average Dermal Response Score at 48 Hours Post Patch Removal

  Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.

  At Day 4 (48 hours post patch removal)

Secondary Outcomes (1)

• Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal

  At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal

Study Arms (5)

Test Product 1

EXPERIMENTAL

Participants will topically apply test product 1 via semi occlusive patch.

Other: Experimental Daily Defense Serum A

Test Product 2

EXPERIMENTAL

Participants will topically apply test product 2 via semi occlusive patch.

Other: Experimental Daily Defense Serum C

Test Product 3

EXPERIMENTAL

Participants will topically apply test product 3 via semi occlusive patch.

Other: Experimental Daily Defense Serum G

Test Product 4

EXPERIMENTAL

Participants will topically apply test product 4 via semi occlusive patch.

Other: Experimental Daily Defense Serum N

Reference Product

SHAM COMPARATOR

Participants will topically apply Reference product via semi occlusive patch.

Other: Saline Solution Sodium Chloride

Interventions

Experimental Daily Defense Serum A OTHER

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

Test Product 1

Experimental Daily Defense Serum C OTHER

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

Test Product 2

Experimental Daily Defense Serum G OTHER

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

Test Product 3

Experimental Daily Defense Serum N OTHER

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

Test Product 4

Saline Solution Sodium Chloride OTHER

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

Reference Product

Eligibility Criteria

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

You may qualify if:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• General health: Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination and participants must have intact skin on the proposed application site; dorsum (scapular region).
• Fitzpatrick photo type I to IV.
• Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.

You may not qualify if:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Women who are breast-feeding.
• Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
• Presence of open sores, pimples, or cysts at the application site.
• Active dermatosis (local or disseminated) that might interfere with the results of the study
• Considered immune compromised.
• History of diseases aggravated or triggered by ultraviolet radiation.
• Participants with dermatographism.
• Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the participant at undue risk.
• Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before Screening visit.
• Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
• Intention of being vaccinated during the study period or vaccination within 3 weeks of the Screening visit.
• Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit 1, or expects to begin injections during study participation.
• Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication.
• Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredients, including any component of the patches.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Valinhos, 13271-130, Brazil

Location

GSK Investigational Site

Valinhos, 13271-, Brazil

Location

Related Links

• Related Info

MeSH Terms

Interventions

Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 28, 2017
• Study Start: May 22, 2017
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: January 16, 2019
• Results First Posted: September 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)