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Trial record 2 of 318 for:    skin care | skin care

A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.

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ClinicalTrials.gov Identifier: NCT04557371
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study aims to determine the local cutaneous and ocular tolerance of 3 developmental skin-care products; a serum, a lotion, and a cream in healthy female subjects with clinically evaluated sensitive facial skin for 21 days.

Condition or disease Intervention/treatment Phase
Skin Care Other: Serum Other: Lotion Other: Cream Not Applicable

Detailed Description:
This will be a randomized, non-comparative, single-blind (evaluator), 3-arm, parallel-group, single-center, clinical 'in-use' study to determine the local cutaneous and ocular tolerance profiles of 3 developmental cosmetic facial skincare products; a serum, lotion, and cream in healthy females with clinically-evaluated sensitive skin as determined by a positive response to a Lactic Acid Stinging Test (LAST) with signs or symptoms of cutaneous irritation and no ophthalmological conditions. Assessments will be performed and recorded for 21 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a randomized, 3-arm parallel group study.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Evaluator-blind
Primary Purpose: Treatment
Official Title: A Clinical Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Cosmetic Facial Skin Care Formulations in Healthy Females With Clinically Assessed Sensitive Skin.
Actual Study Start Date : October 12, 2020
Actual Primary Completion Date : December 22, 2020
Actual Study Completion Date : December 22, 2020

Arm Intervention/treatment
Experimental: Developmental Serum
The participants will apply a developmental serum topically to the face twice daily (morning and evening) to freshly cleansed with normal moisturizing routine for 21 days.
Other: Serum
Participants will topically apply the serum to the face as per normal home use application in place of their current facial serum product.

Experimental: Developmental Lotion
The participants will apply a developmental lotion topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days.
Other: Lotion
Participants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product.

Experimental: Developmental Cream
The participants will apply a developmental cream topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days.
Other: Cream
Participants will topically apply cream to the face as per normal home use application in place of their current facial cream product.




Primary Outcome Measures :
  1. Local cutaneous tolerance assessment of participants for irritation determined by a dermatologist on Day 21 of product use [ Time Frame: Day 21 ]
    A qualified dermatologist will assess the signs and symptoms of cutaneous irritation for 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 edemas. Total possible score range is 0 to 12 where higher value indicates more cutaneous irritation.


Secondary Outcome Measures :
  1. Local ocular tolerance assessment of participants for irritation determined by an ophthalmologist on Day 21 of product use [ Time Frame: Day 21 ]
    A qualified ophthalmologist will visually assess the signs and symptoms of ocular irritation for ocular eczema of the eyelid, conjunctivitis, follicles and chemosis conjunctivae on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Ocular irritation total score = ocular score of eczema of the eyelid + ocular score of conjunctivitis + ocular score of follicles + ocular score of chemosis conjunctivae. Total possible score range is 0 to 12 where higher value indicates more ocular irritation.

  2. Change from baseline in participant self-assessment scores of sign and symptoms of cutaneous irritation after 1 to 2 hours of first product application [ Time Frame: Baseline and 1-2 hours post first use ]
    To evaluate the local cutaneous, participants were instructed to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching and tightness on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of cutaneous irritation total score = redness + dryness + itching + stinging/burning + tightness. Total possible score range is 0 to 15, where higher value indicates more cutaneous irritation. Change from baseline at 1 to 2 hours post first use = total score at 1 to 2 hours minus total score at baseline.

  3. Change from baseline in participant self-assessment scores of sign and symptoms of cutaneous irritation after 21 days of product use [ Time Frame: Baseline and Day 21 ]
    To evaluate the local cutaneous, participants were instructed to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching and tightness on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of cutaneous irritation total score = redness + dryness + itching + stinging/burning + tightness. Total possible score range is 0 to 15, where higher value indicates more cutaneous irritation. Change from baseline at 21 days of product use = total score at Day 21 minus total score at baseline.

  4. Change from baseline in participant self-assessment scores of sign and symptoms of ocular irritation after 1 to 2 hours of first product application [ Time Frame: Baseline and 1-2 hours post first use ]
    To evaluate the ocular tolerance, participants were instructed to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning and itching on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of ocular irritation total score = redness + dryness + itching + stinging/burning. Total possible score range is 0 to 12, where higher value indicates more ocular irritation. Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline.

  5. Change from baseline in participant self-assessment scores of sign and symptoms of ocular irritation after 21 days of product use [ Time Frame: Baseline and Day 21 ]
    To evaluate the ocular tolerance, participants were instructed to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning and itching on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of ocular irritation total score = redness + dryness + itching + stinging/burning. Total possible score range is 0 to 12, where higher value indicates more ocular irritation. Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • A participant who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures.
  • A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee , no clinically significant/relevant abnormalities in medical history or upon dermatologist and ophthalmologist examination, or condition, that would impact the participant's safety, well-being 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.
  • Participants with sensitive facial skin, defined as a positive response to a LAST in the nasolabial area.
  • A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for erythema per dermatological evaluation.
  • A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for dryness per dermatological evaluation.
  • A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for scaling per dermatological evaluation.
  • A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for edema per dermatological evaluation.
  • A participant with an ophthalmologist total signs and symptoms of ocular irritation score of zero (0) per dermatological evaluation.

Exclusion Criteria:

  • A participant 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 participant 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 participant who is pregnant (self-reported) or intends to become pregnant during the study duration.
  • A participant who is breastfeeding.
  • A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • A participant unwilling or unable to comply with the protocol lifestyle considerations required by this study, as described in this protocol.
  • A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
  • A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
  • A participant 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 participant presenting open sores, pimples, or cysts at the application site (face).
  • A participant considered immune-compromised.
  • A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS), and/or corticosteroids.
  • A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
  • A participant who has been vaccinated up to 1 month before the screening visit or who is intending to receive a vaccination during their participation in the study.
  • A participant with a recent history (within the last 5 years) of alcohol or other substance abuse.
  • A participant with any skin marks on the face that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
  • A participant who has previously been enrolled in this study.
  • A participant 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 participant inappropriate for entry into this study.
  • Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperaemia or other active ocular diseases.
  • A participant currently using any medication which in the opinion of the investigator (medically qualified designee) may affect the evaluation of the investigational product or place the participant at undue risk.
  • A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study.
  • A participant with a dermatologist signs and symptoms of cutaneous irritation score of 3 (severe) for edema, scaling, erythema, or dryness per dermatological evaluation.
  • A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557371


Locations
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Germany
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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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)
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04557371    
Other Study ID Numbers: 213059
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Glycerol
Niacinamide
Skin Care