Trial Outcomes & Findings for To Investigate the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleanser in Healthy Females With Sensitive Skin (NCT NCT03172364)

Last Updated: 2019-04-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

122 participants

Primary outcome timeframe

After 21 (+2) days of test product use

Results posted on

2019-04-02

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	55	58
Overall Study COMPLETED	53	57
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Product 1 n=55 Participants All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 Participants 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.	Total n=113 Participants Total of all reporting groups
Age, Continuous	45.9 Years STANDARD_DEVIATION 13.54 • n=5 Participants	46.9 Years STANDARD_DEVIATION 12.82 • n=7 Participants	46.4 Years STANDARD_DEVIATION 13.13 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	58 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	35 Participants n=5 Participants	46 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Product 1 n=55 Participants All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 Participants 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.
Frequency of Combined Dermatologist Score At Day 21, score 1	3 Participants	2 Participants
Frequency of Combined Dermatologist Score At Day 21, Missing	1 Participants	1 Participants
Frequency of Combined Dermatologist Score At Day 21, score 0	51 Participants	55 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product 1 n=55 Participants All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 Participants 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.
Frequency of Combined Ophthalmologist Score At Day 21, Missing	1 Participants	1 Participants
Frequency of Combined Ophthalmologist Score At Day 21, Score 0	54 Participants	57 Participants
Frequency of Combined Ophthalmologist Score At Day 21, Score 1	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product 1 n=55 Participants All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 Participants 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.
Frequency of Combined Dermatologist and Ophthalmologist Score At Day 21, 1	3 Participants	2 Participants
Frequency of Combined Dermatologist and Ophthalmologist Score At Day 21, Missing	1 Participants	1 Participants
Frequency of Combined Dermatologist and Ophthalmologist Score At Day 21, 0	51 Participants	55 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product 1 n=55 Participants All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 Participants 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.
Combined Dermatologist and Ophthalmologist Score (Modified) At Day 21, Missing	1 Participants	1 Participants
Combined Dermatologist and Ophthalmologist Score (Modified) At Day 21, 0	51 Participants	55 Participants
Combined Dermatologist and Ophthalmologist Score (Modified) At Day 21, 1	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product 1 n=55 Participants All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 Participants 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.
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Baseline, Missing	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Baseline, 0=None	48 Participants	50 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Baseline, 1=Mild	7 Participants	6 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Baseline, 2=Moderate	0 Participants	2 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Baseline, 3=Severe	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Day 21, Missing	1 Participants	1 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Day 21, 0=None	48 Participants	45 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Day 21, 1=Mild	6 Participants	11 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Day 21, 2=Moderate	0 Participants	1 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face At Day 21, 3=Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Test Product 1 n=55 Participants All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 Participants 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.
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Baseline, Missing	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Baseline, 0	55 Participants	58 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Baseline, 1	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Baseline, 2	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Baseline, 3	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Day 21, Missing	1 Participants	1 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Day 21, 0	54 Participants	57 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Day 21, 1	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Day 21, 2	0 Participants	0 Participants
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye At Day 21, 3	0 Participants	0 Participants

Adverse Events

Test Product 1

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Test Product 2

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Product 1 n=55 participants at risk All the participants in this arm will receive test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.	Test Product 2 n=58 participants at risk All the participants in this arm will receive test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.
Skin and subcutaneous tissue disorders RASH MACULAR	1.8% 1/55 • Approximately 21 days	0.00% 0/58 • Approximately 21 days
Skin and subcutaneous tissue disorders ACNE	0.00% 0/55 • Approximately 21 days	1.7% 1/58 • Approximately 21 days
Skin and subcutaneous tissue disorders PAPULE	0.00% 0/55 • Approximately 21 days	1.7% 1/58 • Approximately 21 days
Eye disorders DRY EYE	1.8% 1/55 • Approximately 21 days	0.00% 0/58 • Approximately 21 days
Eye disorders OCULAR HYPERAEMIA	1.8% 1/55 • Approximately 21 days	0.00% 0/58 • Approximately 21 days
Infections and infestations INFLUENZA	1.8% 1/55 • Approximately 21 days	0.00% 0/58 • Approximately 21 days
Infections and infestations ORAL HERPES	1.8% 1/55 • Approximately 21 days	0.00% 0/58 • Approximately 21 days
Skin and subcutaneous tissue disorders DRY SKIN	1.8% 1/55 • Approximately 21 days	1.7% 1/58 • Approximately 21 days
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	0.00% 0/55 • Approximately 21 days	1.7% 1/58 • Approximately 21 days
Gastrointestinal disorders LIP ULCERATION	1.8% 1/55 • Approximately 21 days	0.00% 0/58 • Approximately 21 days
Injury, poisoning and procedural complications THERMAL BURN	1.8% 1/55 • Approximately 21 days	0.00% 0/58 • Approximately 21 days

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER