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

A Clinical Study to Assess the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleansers in Healthy Females With Sensitive Skin Under Normal Conditions of Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03172364
Enrollment
122
Registered
2017-06-01
Start date
2017-06-12
Completion date
2017-07-13
Last updated
2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Care

Brief 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.

Detailed description

This is an assessor blind (dermatologist and ophthalmologist) clinical in use study to determine the local cutaneous and ocular tolerance of two cosmetic facial cleanser products when used as per the intended instructions for use in a population of healthy female participants with clinically assessed sensitive skin.

Interventions

OTHERMicellar cleanser

Participants will apply the micellar cleanser topically twice a day (morning and evening). Micellar cleanser will be applied on cotton pad and wiped over the entire face and closed eye to gently cleanse. No need to rub or rinse the micellar cleanser.

OTHERMicellar foaming cleanser

Participants will use the micellar foaming cleanser topically twice a day (morning and evening). Micellar foaming cleanser will be massaged gently onto wet skin on the face using fingertips. After which participants will rinse thoroughly and pat the skin dry.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Combined Dermatologist ScoreAfter 21 (+2) days of test product useThe intensity of any visual signs of irritation was recorded according to Dermal response score: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal popular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, and 7=Strong reaction spreading beyond test site. Dermatologist also provided a superficial irritation score if the dermal response score \>0. Superficial irritation score was as follow: grade A/score 0=Slight glazed appearance, grade B/score 1=Marked glazing, grade C/score 2=Glazing with peeling and cracking, grade F/score 3=Glazing with fissures, grade G/score 3=Film of dried serous exudate covering all or portion of the patch, and grade H/score 3=Small petechial erosions and/or scabs. The combined score was equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score. Full range 0-10.
Frequency of Combined Ophthalmologist ScoreAfter 21 (+2) days of test product useOcular irritation assessed through the observation of the presence of two factors: Lacrimation Intensity and Conjunctiva Involvement. Conjunctiva involvement score are as follow: 0= None - No involvement, 1= Mild - Conjunctivae (palpebral and bulbar) injected above normal with possible chemosis (swelling); no discharge, 2= Moderate - Conjunctivae injected above normal; obvious swelling; possible discharge, and 3= Severe - Conjunctivae more diffuse, deeper crimson red, individual vessels not easily discernible; excessive swelling and/or discharge. Lacrimal intensity score are as follow: 0= None - No lacrimation observed, 1= Mild-Excessive wetness (no distinct tears), 2= Moderate - A few formed tears (contained in orbit), and 3= Severe - Intense tearing (leaving orbit). The combined ophthalmologist score was calculated in the following way: Combined ophthalmologist score = conjunctiva involvement score + lacrimal intensity score. Full range 0-6.
Frequency of Combined Dermatologist and Ophthalmologist ScoreAfter 21 (+2) days of test product useThe combined dermatologist and ophthalmologist score was calculated as the sum of the combined dermatologist score (i.e., dermal response score + superficial irritation score) and the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.
Combined Dermatologist and Ophthalmologist Score (Modified)After 21 (+2) days of test product useA modified combined dermatologist and ophthalmologist score was calculated, where the superficial irritation component was removed from the equation. Therefore, the modified combined dermatologist and ophthalmologist score was defined as the dermal response score + the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.

Secondary

MeasureTime frameDescription
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceBaseline and after 21 (+2) days of test product useParticipants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your face?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Combined score face was obtained by summing the 5 subject assessments for face i.e. redness, dryness, burning, itching and stinging. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeBaseline and after 21 (+2) days of test product useParticipants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your eyes?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.

Countries

Brazil

Participant flow

Recruitment details

All the participants were enrolled from one center in Campinas, Sao Paulo, Brazil.

Pre-assignment details

A total of 190 participants were screened for the study, out of which 122 participants were enrolled and 68 participants were not eligible to meet study criteria. Out of 122 enrolled participants, 113 were randomized. Out of 77 nonrandomized participants, 73 did not meet the study criteria, 1 had an adverse event (AE), and 3 were lost to follow-up.

Participants by arm

ArmCount
Test Product 1
All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
55
Test Product 2
All the participants in this arm received test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.
58
Total113

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event11
Overall StudyProtocol Violation10

Baseline characteristics

CharacteristicTest Product 2TotalTest Product 1
Age, Continuous46.9 Years
STANDARD_DEVIATION 12.82
46.4 Years
STANDARD_DEVIATION 13.13
45.9 Years
STANDARD_DEVIATION 13.54
Race/Ethnicity, Customized
African American/African Heritage
5 Participants12 Participants7 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian - East Asian Heritage
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian - Japanese Heritage
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Asian - South East Asian Heritage
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Multiple
6 Participants17 Participants11 Participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White - Arabic/North African Heritage
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
46 Participants81 Participants35 Participants
Sex: Female, Male
Female
58 Participants113 Participants55 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 58
other
Total, other adverse events
5 / 554 / 58
serious
Total, serious adverse events
0 / 550 / 58

Outcome results

Primary

Combined Dermatologist and Ophthalmologist Score (Modified)

A modified combined dermatologist and ophthalmologist score was calculated, where the superficial irritation component was removed from the equation. Therefore, the modified combined dermatologist and ophthalmologist score was defined as the dermal response score + the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.

Time frame: After 21 (+2) days of test product use

Population: ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Test Product 1Combined Dermatologist and Ophthalmologist Score (Modified)At Day 21, Missing1 Participants
Test Product 1Combined Dermatologist and Ophthalmologist Score (Modified)At Day 21, 051 Participants
Test Product 1Combined Dermatologist and Ophthalmologist Score (Modified)At Day 21, 13 Participants
Test Product 2Combined Dermatologist and Ophthalmologist Score (Modified)At Day 21, Missing1 Participants
Test Product 2Combined Dermatologist and Ophthalmologist Score (Modified)At Day 21, 055 Participants
Test Product 2Combined Dermatologist and Ophthalmologist Score (Modified)At Day 21, 12 Participants
Primary

Frequency of Combined Dermatologist and Ophthalmologist Score

The combined dermatologist and ophthalmologist score was calculated as the sum of the combined dermatologist score (i.e., dermal response score + superficial irritation score) and the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.

Time frame: After 21 (+2) days of test product use

Population: ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Test Product 1Frequency of Combined Dermatologist and Ophthalmologist ScoreAt Day 21, Missing1 Participants
Test Product 1Frequency of Combined Dermatologist and Ophthalmologist ScoreAt Day 21, 051 Participants
Test Product 1Frequency of Combined Dermatologist and Ophthalmologist ScoreAt Day 21, 13 Participants
Test Product 2Frequency of Combined Dermatologist and Ophthalmologist ScoreAt Day 21, Missing1 Participants
Test Product 2Frequency of Combined Dermatologist and Ophthalmologist ScoreAt Day 21, 055 Participants
Test Product 2Frequency of Combined Dermatologist and Ophthalmologist ScoreAt Day 21, 12 Participants
Primary

Frequency of Combined Dermatologist Score

The intensity of any visual signs of irritation was recorded according to Dermal response score: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal popular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, and 7=Strong reaction spreading beyond test site. Dermatologist also provided a superficial irritation score if the dermal response score \>0. Superficial irritation score was as follow: grade A/score 0=Slight glazed appearance, grade B/score 1=Marked glazing, grade C/score 2=Glazing with peeling and cracking, grade F/score 3=Glazing with fissures, grade G/score 3=Film of dried serous exudate covering all or portion of the patch, and grade H/score 3=Small petechial erosions and/or scabs. The combined score was equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score. Full range 0-10.

Time frame: After 21 (+2) days of test product use

Population: Intent to Treat (ITT, N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application. No inferential statistic were performed for this outcome.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Test Product 1Frequency of Combined Dermatologist ScoreAt Day 21, Missing1 Participants
Test Product 1Frequency of Combined Dermatologist ScoreAt Day 21, score 051 Participants
Test Product 1Frequency of Combined Dermatologist ScoreAt Day 21, score 13 Participants
Test Product 2Frequency of Combined Dermatologist ScoreAt Day 21, Missing1 Participants
Test Product 2Frequency of Combined Dermatologist ScoreAt Day 21, score 055 Participants
Test Product 2Frequency of Combined Dermatologist ScoreAt Day 21, score 12 Participants
Primary

Frequency of Combined Ophthalmologist Score

Ocular irritation assessed through the observation of the presence of two factors: Lacrimation Intensity and Conjunctiva Involvement. Conjunctiva involvement score are as follow: 0= None - No involvement, 1= Mild - Conjunctivae (palpebral and bulbar) injected above normal with possible chemosis (swelling); no discharge, 2= Moderate - Conjunctivae injected above normal; obvious swelling; possible discharge, and 3= Severe - Conjunctivae more diffuse, deeper crimson red, individual vessels not easily discernible; excessive swelling and/or discharge. Lacrimal intensity score are as follow: 0= None - No lacrimation observed, 1= Mild-Excessive wetness (no distinct tears), 2= Moderate - A few formed tears (contained in orbit), and 3= Severe - Intense tearing (leaving orbit). The combined ophthalmologist score was calculated in the following way: Combined ophthalmologist score = conjunctiva involvement score + lacrimal intensity score. Full range 0-6.

Time frame: After 21 (+2) days of test product use

Population: ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application. No inferential statistic were performed for this outcome.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Test Product 1Frequency of Combined Ophthalmologist ScoreAt Day 21, Missing1 Participants
Test Product 1Frequency of Combined Ophthalmologist ScoreAt Day 21, Score 054 Participants
Test Product 1Frequency of Combined Ophthalmologist ScoreAt Day 21, Score 10 Participants
Test Product 2Frequency of Combined Ophthalmologist ScoreAt Day 21, Missing1 Participants
Test Product 2Frequency of Combined Ophthalmologist ScoreAt Day 21, Score 057 Participants
Test Product 2Frequency of Combined Ophthalmologist ScoreAt Day 21, Score 10 Participants
Secondary

Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye

Participants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your eyes?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.

Time frame: Baseline and after 21 (+2) days of test product use

Population: ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, Missing0 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 055 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 10 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 20 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 30 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, Missing1 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 054 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 10 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 20 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 30 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 10 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, Missing0 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, Missing1 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 058 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 30 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 10 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 057 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 20 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Day 21, 20 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on EyeAt Baseline, 30 Participants
Secondary

Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face

Participants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your face?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Combined score face was obtained by summing the 5 subject assessments for face i.e. redness, dryness, burning, itching and stinging. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.

Time frame: Baseline and after 21 (+2) days of test product use

Population: ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, Missing0 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 0=None48 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 1=Mild7 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 2=Moderate0 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 3=Severe0 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, Missing1 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 0=None48 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 1=Mild6 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 2=Moderate0 Participants
Test Product 1Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 3=Severe0 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 1=Mild11 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, Missing0 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, Missing1 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 0=None50 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 3=Severe0 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 1=Mild6 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 0=None45 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 2=Moderate2 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Day 21, 2=Moderate1 Participants
Test Product 2Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on FaceAt Baseline, 3=Severe0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026