Trial Outcomes & Findings for A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis (NCT NCT01915914)

NCT ID: NCT01915914

Last Updated: 2018-10-12

Results Overview

Time to the first relapse of AD is defined as the number of days from start of the FP treatment in Maintenance Phase until AD relapse. AD relapse is defined as participants with PSGA exacerbation score \>=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during Acute Phase. Participants with treatment success are defined as participants with PSGA \<=1; and the improvement \>=2 compared to Baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

107 participants

Primary outcome timeframe

From the start of treatment up to Week 20 during the Maintenance Phase

Results posted on

2018-10-12

Participant Flow

Number of enrolled participants n=123 in Acute Phase and n=107 in Maintenance Phase (ITT Population).

Eligible participants (par.) received twice daily (BID) fluticasone propionate 0.05% (FP) cream up to 4 weeks (wk) (in Acute Phase), then par. received (1:1) either emollient BID plus FP cream once daily (OD) twice a wk, or emollient BID up to 20 wk (Maintenance Phase). Par. who did not relapse received emollient BID up to 12 wk (Follow-up Phase).

Participant milestones

Participant milestones
Measure	FP 0.05% Cream Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.	Emollient Plus FP 0.05% Cream Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.	Follow-up: Emollient Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
Acute Phase STARTED	123	0	0	0
Acute Phase Completed-Not Entered Maintenance Phase	4	0	0	0
Acute Phase COMPLETED	111	0	0	0
Acute Phase NOT COMPLETED	12	0	0	0
Maintenance Phase STARTED	0	54	53	0
Maintenance Phase COMPLETED	0	48	51	0
Maintenance Phase NOT COMPLETED	0	6	2	0
Follow-up Phase STARTED	0	0	0	66
Follow-up Phase COMPLETED	0	0	0	64
Follow-up Phase NOT COMPLETED	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	FP 0.05% Cream Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.	Emollient Plus FP 0.05% Cream Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.	Follow-up: Emollient Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
Acute Phase Withdrawal by Subject	4	0	0	0
Acute Phase Lost to Follow-up	4	0	0	0
Acute Phase Physician Decision	1	0	0	0
Acute Phase Accepted Other Topic Therapies	1	0	0	0
Acute Phase Not Achieved "treatment success"	1	0	0	0
Acute Phase Missing	1	0	0	0
Maintenance Phase Withdrawal by Subject	0	1	1	0
Maintenance Phase Lost to Follow-up	0	4	1	0
Maintenance Phase Missing	0	1	0	0
Follow-up Phase Withdrawal by Subject	0	0	0	1
Follow-up Phase Physician Decision	0	0	0	1

Baseline Characteristics

A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=123 Participants Participants who entered the Acute Phase received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to the affected sites and any newly occurring atopic dermatitis (AD) sites. The efficacy and safety in the Acute Phase assessed every 2 weeks up to 4 weeks or until treatment success. Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with physician static global assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, participants received emollient BID plus FP 0.05% cream OD twice a week, or emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
Age, Continuous	4.8 Years STANDARD_DEVIATION 2.58 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	118 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the start of treatment up to Week 20 during the Maintenance Phase

Population: ITT Population: all participants who were randomized into the Maintenance Phase. Only participants available at the specified time point were analyzed.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Time to the First Relapse of AD During the Maintenance Phase	NA Days Limited number of participants had AD relapse during the study; therefore, the Median and CI could not be provided.	142.0 Days Interval 50.0 to 150.0

SECONDARY outcome

Timeframe: From the start of treatment up to Week 32 during the Maintenance Phase and Follow-up Phase

Population: ITT Population. Only participants avilable at the specified time point were analyzed.

Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase is defined as the number of days from start of the FP treatment until AD relapse during the Maintenance Phase and Follow-up Phase. AD relapse is defined as participants with PSGA exacerbation score \>=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during the Acute Phase.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Median Time to the First Relapse of AD During the Maintenance Phase and Follow-up Phase	NA Days Limited number of participants had AD relapse during the study; therefore, the Median and CI could not be provided.	142.0 Days Interval 50.0 to Limited number of participants had AD relapse during the study; therefore, the upper limit of CI could not be provided.

SECONDARY outcome

Timeframe: From Week 0 (or treatment success, if earlier) to Week 20

Population: ITT Population

The number of participants with AD recurrent/relapse at the end of Maintenance Phase is presented. AD relapse is defined as participants with PSGA exacerbation score \>=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA \<=1; and the improvement \>=2 compared to Baseline.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Numbers of Recurrent Participants at the End of the Maintenance Phase (Week 20)	3 Participants	30 Participants

SECONDARY outcome

Timeframe: From Week 20 to Week 32

Population: ITT Population

The number of participants with AD recurrent/relapse at the end of the Follow-up Phase is presented. AD relapse is defined as participants with PSGA exacerbation score \>=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA \<=1; and the improvement \>=2 compared to Baseline.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Numbers of Recurrent Participants at the End of the Follow-up Phase (Week 32)	10 Participants	32 Participants

SECONDARY outcome

Timeframe: From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)

Population: Enrolled Population: all participants who were enrolled into the Acute Phase of the study.

The number of participants with "treatment success" during the Acute Phase is presented. Participants with treatment success are defined as participants with PSGA \<=1; and the improvement \>=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to Baseline in the Acute Phase of the study.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=123 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Number of Participants With "Treatment Success" During the Acute Phase	107 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: ITT Population

Infant's Dermatitis Quality of Life Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with atopic dermatitis, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in the QoL score is based on each questionnaire at the end of the Maintenance Phase and is calculated as the score at the end of the Maintenance Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is \< 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Change From Baseline in Quality of Life (QoL) at the End of the Maintenance Phase	-0.4 Scores on a scale Standard Deviation 4.40	2.2 Scores on a scale Standard Deviation 4.68

SECONDARY outcome

Timeframe: Baseline and Week 32

Population: ITT Population

Infant's IDQOL and Children's CDLQI were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with AD, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in QoL score is based on each questionnaire at the end of the Follow-up Phase and is calculated as the score at the end of the Follow-up Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is \< 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Change From Baseline in QoL at the End of the Follow-up Phase	0.0 Scores on a scale Standard Deviation 4.97	2.2 Scores on a scale Standard Deviation 5.10

SECONDARY outcome

Timeframe: At early withdrawal or end of the therapy visit (up to Week 32)

Population: ITT Population

Participants from each group completed the post-study questionnaire to rate the skin emollients (gel, lotion, cream, ointment, solution and foam) used in the past based on their experience. Participants rated skin emollients on a 5-point scale (5= "liked the best", 4= "second best", 3= "third best", 2= "fourth best, 1= "liked the least", N/A=Does not apply to me).

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Lotion, 4	8 Participants	12 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Lotion, 5	27 Participants	26 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Gel, 1	2 Participants	1 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Gel, 2	2 Participants	1 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Gel, 3	2 Participants	2 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Gel, 4	2 Participants	2 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Gel, 5	1 Participants	0 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Gel, N/A	39 Participants	44 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Lotion, 1	1 Participants	1 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Lotion, 2	0 Participants	1 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Lotion, 3	7 Participants	2 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Lotion, N/A	5 Participants	8 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Cream, 1	1 Participants	0 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Cream, 2	1 Participants	2 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Cream, 3	7 Participants	2 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Cream, 4	12 Participants	18 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Cream, 5	6 Participants	5 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Cream, N/A	21 Participants	23 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Ointment, 1	1 Participants	3 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Ointment, 2	7 Participants	3 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Ointment, 3	5 Participants	10 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Ointment, 4	3 Participants	3 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Ointment, 5	10 Participants	11 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Ointment, N/A	22 Participants	20 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Solution, 1	0 Participants	1 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Solution, 2	1 Participants	0 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Solution, 3	4 Participants	5 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Solution, 4	4 Participants	2 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Solution, 5	1 Participants	0 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Solution, N/A	38 Participants	42 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Foam, 1	4 Participants	2 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Foam, 2	1 Participants	1 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Foam, 3	1 Participants	0 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Foam, 4	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Foam, 5	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire Foam, N/A	42 Participants	47 Participants

SECONDARY outcome

Timeframe: At early withdrawal or end of the therapy visit (up to Week 32)

Population: Enrolled Population

Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: This product is easier to use than other skin emollients; Q 2: When I apply this product I am able to start my daily activities quicker than with other skin emollients; Q 3: This product leaves my skin feeling softer than other skin emollients; Q 4: I am able to apply this product to larger body surface areas than other skin emollients; Q 5: This product disappears into my skin quicker than when I apply other skin emollients. Participants rated the qualities of the lotion based on a 5 point scale (5= "Strongly Agree", 4= "Agree", 3= "Neutral", 2= "Disagree", 1= "Strongly Disagree" N/A=Does not apply to me). Participant's rating for each question were summarized.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 1, N/A	4 Participants	4 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 2, 3	5 Participants	13 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 3, 3	4 Participants	9 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 3, N/A	4 Participants	4 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 1, 1	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 1, 2	0 Participants	4 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 2, 1	0 Participants	1 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 2, 2	1 Participants	2 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 1, 3	5 Participants	13 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 1, 4 or 5	39 Participants	29 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 2, 4 or 5	38 Participants	29 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 2, N/A	4 Participants	5 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 3, 1	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 3, 2	1 Participants	3 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 3, 4 or 5	39 Participants	34 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 4, 1	0 Participants	1 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 4, 2	0 Participants	1 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 4, 3	6 Participants	7 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 4, 4 or 5	38 Participants	37 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 4, N/A	4 Participants	4 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 5, 1	0 Participants	2 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 5, 2	0 Participants	2 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 5, 3	6 Participants	10 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 5, 4 or 5	38 Participants	32 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire Q 5, N/A	4 Participants	4 Participants

SECONDARY outcome

Timeframe: At early withdrawal or end of the therapy visit (up to Week 32)

Population: ITT Population

Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: It leaves my skin feeling soft and smooth; Q 2: There is nothing left on my skin; Q 3: Does not feel greasy; Q 4: Disappears into my skin quickly after I put it on; Q 5: Easy to apply; Q 6: Fragrance-free; Q 7: Spreadability; Q 8: Lack of stickiness. Participants rated the qualities of the lotion based on a 5 point scale (5= "Strongly Agree", 4= "Agree", 3= "Neutral", 2= "Disagree", 1= "Strongly Disagree" N/A=Does not apply to me). Participant's rating for each question were summarized.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 1, 1	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 1, 2	1 Participants	1 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 1, 3	3 Participants	11 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 1, 4 or 5	44 Participants	37 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 1, N/A	0 Participants	1 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 2, 1	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 2, 2	3 Participants	4 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 2, 3	1 Participants	8 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 2, 4 or 5	44 Participants	38 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 2, N/A	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 3, 1	0 Participants	2 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 3, 2	3 Participants	3 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 3, 3	2 Participants	10 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 3, 4 or 5	43 Participants	35 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 3, N/A	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 4, 1	0 Participants	2 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 4, 2	1 Participants	3 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 4, 3	2 Participants	7 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 4, 4 or 5	45 Participants	38 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 4, N/A	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 5, 1	0 Participants	2 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 5, 2	1 Participants	1 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 5, 3	2 Participants	5 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 5, 4 or 5	45 Participants	42 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 5, N/A	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 6, 1	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 6, 2	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 6, 3	1 Participants	5 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 6, 4 or 5	47 Participants	45 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 6, N/A	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 7, 1	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 7, 2	1 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 7, 3	2 Participants	9 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 7, 4 or 5	45 Participants	41 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 7, N/A	0 Participants	0 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 8, 1	0 Participants	2 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 8, 2	3 Participants	3 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 8, 3	2 Participants	10 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 8, 4 or 5	43 Participants	35 Participants
Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire Q 8, N/A	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)

Population: Enrolled Population

Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each signs (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Acute Phase (Visit 4 \[Week 0 or treatment success, depend on which time point comes first) ±2day\]) and is calculated as the score at Visit 4 minus the Baseline score. Baseline is defined as the VAS score for each sign obtained before the first dose of study drug in the Acute Phase of the study (Visit 2). Summation of the VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at Visit 4 of the Acute Phase of the study.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=123 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase Visit 4, CA	-0.3 Scores on a scale Standard Deviation 1.12	—
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase Visit 4, ET/L	-1.9 Scores on a scale Standard Deviation 1.57	—
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase Visit 4, AP	-0.7 Scores on a scale Standard Deviation 1.47	—
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase Visit 4, Total VAS Score	-2.9 Scores on a scale Standard Deviation 3.14	—

SECONDARY outcome

Timeframe: Baseline, Week 20 and Week 32

Population: ITT Population

Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using the Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each sign (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Maintenance Phase and Follow-up Phase and is calculated as the score at the end of the Maintenance and Follow-up Phase minus the Baseline score. Baseline is defined as VAS score for each sign obtained at Visit 4 (end of Acute Phase). Summation of VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at the Maintenance and Follow-up phase of study. The missing value was imputed using last-observation-carry-forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Emollient Plus FP 0.05% Cream n=54 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 Participants Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA \<=1; and the improvement \>=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 20, CA	-0.1 Scores on a scale Standard Deviation 0.44	-0.2 Scores on a scale Standard Deviation 1.01
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 20, ET/L	-0.4 Scores on a scale Standard Deviation 1.49	0.5 Scores on a scale Standard Deviation 1.51
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 20, AP	-0.4 Scores on a scale Standard Deviation 1.42	0.0 Scores on a scale Standard Deviation 1.32
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 32, CA	-0.1 Scores on a scale Standard Deviation 0.58	-0.2 Scores on a scale Standard Deviation 1.03
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 32, ET/L	0.1 Scores on a scale Standard Deviation 1.19	0.6 Scores on a scale Standard Deviation 1.53
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 32, AP	-0.3 Scores on a scale Standard Deviation 1.23	0.0 Scores on a scale Standard Deviation 1.35
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 20, Total VAS Score	-0.9 Scores on a scale Standard Deviation 2.61	0.3 Scores on a scale Standard Deviation 2.75
Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase Week 32, Total VAS Score	-0.3 Scores on a scale Standard Deviation 2.09	0.4 Scores on a scale Standard Deviation 2.82

Adverse Events

FP 0.05% Cream

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Emollient Plus FP 0.05% Cream

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Emollient

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Follow-up: Emollient

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FP 0.05% Cream n=116 participants at risk Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety of FP 0.05% cream was assessed every 2 weeks up to 4 weeks or until treatment success.	Emollient Plus FP 0.05% Cream n=53 participants at risk Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.	Emollient n=53 participants at risk Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.	Follow-up: Emollient n=66 participants at risk Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
Infections and infestations Bronchitis	0.00% 0/116 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	1.9% 1/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/116 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	1.9% 1/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.
Infections and infestations Infectious mononucleosis	0.00% 0/116 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	1.9% 1/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.
Infections and infestations Mycoplasma infection	0.00% 0/116 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	1.9% 1/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/53 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.	0.00% 0/66 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study drug until follow-up (last dose of study treatment (emollient), up to Week 32). SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants who received study therapy during the Acute Phase, Maintenance Phase and Follow-up Phase and have a safety assessment in the Acute Phase, Maintenance Phase and Follow-up Phase of the study.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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