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N/A N=113 Randomized Single-blind Basic Science

To Investigate the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleanser in Healthy Females With Sensitive Skin

Skin Care

Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Frequency of Combined Dermatologist Score — 1; 1; 51; 55 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Micellar cleanser (Other); Micellar foaming cleanser (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
GlaxoSmithKline
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Frequency of Combined Dermatologist Score
1; 1; 51; 55; 3; 2
PRIMARY
Frequency of Combined Ophthalmologist Score
1; 1; 54; 57; 0; 0
PRIMARY
Frequency of Combined Dermatologist and Ophthalmologist Score
1; 1; 51; 55; 3; 2
PRIMARY
Combined Dermatologist and Ophthalmologist Score (Modified)
1; 1; 51; 55; 3; 2
SECONDARY
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face
0; 0; 48; 50; 7; 6
SECONDARY
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye
0; 0; 55; 58; 0; 0

Summary

The objective of this clinical study is to assess the cutaneous and ocular local tolerance of two cosmetic facial cleansers in healthy female participants with sensitive skin under normal conditions of use.

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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 (dermatologist or ophthalmologist) examination
  • Fitzpatrick phototype I to IV
  • Sensitive Skin (as determined by the lactic acid Stinging test)
  • Dermatologist score of zero
  • Ophthalmologist score of zero
  • Dermatologist assessed Dry or Normal/Combination Skin
  • Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
  • Frequent use of facial cosmetic make-up, including eye-make-up (5 out of 7 days per week)

Exclusion Criteria

  • 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
  • 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 and during the study
  • Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit and during the study
  • Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit
  • Currently receiving allergy injections, or received an allergy injection within 7 days prior to Screening visit, or expects to begin injections during study participation
  • Previous history of atopy with regards to allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  • Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
  • Previous participation in this study
  • Recent history (within the last 5 years) of alcohol or other substance abuse
  • Any participant who, in the judgment of the Investigator, should not participate in the study
  • Any participant with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases
  • 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)
  • Prisoner or involuntary incarcerated participant
  • Participant from an indigenous tribe
  • Participant with a qualified dermatologist assessment of oily skin
  • An employee of the sponsor or the study site or members of their immediate family
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03172364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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