A Clinical Study to Investigate the Dermal and Ocular Tolerance of a Developmental Cosmetic Facial Serum Formulation in Healthy Females With Sensitive Skin

NCT03640832 | Completed Results

• 1 other identifier: 209442
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the local cutaneous and ocular tolerance of a developmental cosmetic facial serum in healthy females with sensitive facial skin under normal conditions of use.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Unit Change of Greater Than (>) 1 in Signs and Symptoms of Cutaneous Irritation Total Scores From Baseline to 21 Days of Product Use

  A qualified dermatologist visually assessed the signs and symptoms of cutaneous irritation for dermal erythema, dryness, scaling, and edema on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Cutaneous irritation total score = dermal score of erythema + dermal score of dryness + dermal score of scaling + dermal score of edema. Total possible score range is 0 to 12 (higher value indicated more cutaneous irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of greater than (\>) 1 in total score (TS) of cutaneous irritation from baseline to 21 days of product use, are reported in this outcome measure.

  Baseline and Day 21

Secondary Outcomes (3)

• Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation Total Scores From Baseline to 21 Days of Product Use

  Baseline and Day 21

• Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use

  Baseline, 1-2 hours post first use, Day 21

• Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use

  Baseline, 1-2 hours post first use, Day 21

Study Arms (2)

Test product

EXPERIMENTAL

All the participant in this arm will receive the test product (development serum). Test product will be applied twice daily to the freshly cleansed skin in place of the participant's current serum and before applying moisturizer.

Other: Developmental Serum

Reference product

ACTIVE COMPARATOR

All the participant in this arm will receive the reference product (Physiogel Calming Relief Anti-Redness Serum). Reference product will be applied twice daily to the freshly cleansed skin in place of the participant's current serum and before applying moisturizer.

Other: Physiogel Calming Relief Anti-Redness Serum

Interventions

Developmental Serum OTHER

A 30millilitre (mL) bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.

Test product

Physiogel Calming Relief Anti-Redness Serum OTHER

A 30mL bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.

Reference product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female who, at the time of screening, is between the ages of 18 and 65 years, inclusive.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provision of a signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study before any assessment is performed.
• A subject who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures.
• A subject in good general and mental health with, in the opinion of the investigator or medically qualified designee (if the investigator is not suitably qualified), no clinically significant/relevant abnormalities in medical history or upon dermatologist and ophthalmologist examination, or condition, that would impact the subject's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
• A subject with sensitive facial skin, defined as a positive response to a lactic acid sting test in the nasolabial area.
• A subject with a dermatologist signs and symptoms of cutaneous irritation score of greater than or equal to 0.5 (very slight) for erythema.
• A subject with a dermatologist signs and symptoms of cutaneous irritation score of greater than or equal to 0.5 (very slight) for dryness.
• A subject with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for scaling.
• A subject with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for edema.
• A subject with an ophthalmologist total signs and symptoms of ocular irritation score of 0 (none).

You may not qualify if:

• A subject who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
• A subject who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
• A subject with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the subject inappropriate for entry into this study.
• A subject who is pregnant (self-reported).
• A subject who is breastfeeding.
• A subject with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A subject who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
• A subject unwilling or unable to comply with the Lifestyle Considerations required by this study, as described in this protocol.
• A subject with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
• A subject with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
• A subject with any history of significant diseases or medical conditions known to alter skin or eye 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.
• A subject presenting open sores, pimples, or cysts at the application site (face).
• A subject with an active dermatosis (local or disseminated) that might interfere with the results of the study.
• A subject with a dermatologist signs and symptoms of cutaneous irritation score of 3 (severe) for erythema, edema, scaling or dryness.
• A subject considered immune-compromised.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  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
• Masking Details: Evaluator blinded (dermatologist and ophthalmologist).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: October 15, 2018
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: November 27, 2020
• Results First Posted: October 1, 2019

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (1)