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Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.

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ClinicalTrials.gov Identifier: NCT01909713
Recruitment Status : Completed
First Posted : July 26, 2013
Results First Posted : March 24, 2014
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Prone Skin
Intervention Drug: Facial Cleanser and Moisturizer SPF 30
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cetaphil® DermaControl™ Regimen.
Hide Arm/Group Description

All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.

Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30

Period Title: Overall Study
Started 35
Completed 35
Not Completed 0
Arm/Group Title Cetaphil® DermaControl™ Regimen.
Hide Arm/Group Description

All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.

Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
9.0  (1.5)
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
9.0
(7.0 to 11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
17
  48.6%
Male
18
  51.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   5.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  25.7%
White
22
  62.9%
More than one race
2
   5.7%
Unknown or Not Reported
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Hispanic or Latino
12
  34.3%
Not Hispanic or Latino
23
  65.7%
Unknown or Not Reported
0
   0.0%
Normal Skin Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants
35
Fitzpatrick Skin Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants
II 7
III 5
IV 3
V 12
VI 8
[1]
Measure Description: Fitzpatrick Skin Type Classification I Always burns; never tans II Burns easily; tans minimally III Burns moderately; tans gradually to light brown IV Burns minimally; tans well to moderate brown V Rarely burns; tans profusely to dark brown VI Never burns; tans profusely to black
Global Severity of Acne  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants
Clear 1
Almost Clear 27
MIld 7
Oiliness Evaluation Score  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants
Not Oily 28
Mildly Oily 7
1.Primary Outcome
Title Cutaneous Tolerability Based on Visual Inspection - Erythema
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
None 29 33 30 29
Very Mild 6 2 4 5
Mild 0 0 1 1
2.Primary Outcome
Title Cutaneous Tolerability Based on Visual Inspection - Edema
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
None 35 35 34 34
Mild 0 0 1 1
3.Primary Outcome
Title Cutaneous Tolerability Based on Visual Inspection - Dryness
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
No Observable Scaling 34 33 32 32
Fine Flakes/Scaling 1 2 3 3
4.Primary Outcome
Title Cutaneous Tolerability Based on Visual Inspection - Roughness
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
No Roughness, Skin is Fine, Silky Smooth 35 34 35 34
Coarse, Rough Skin 0 1 0 1
5.Secondary Outcome
Title Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Itching: 0 = none, no itching; 1 = mild, slight itching, not really bothersome; 2 = moderate, definite itching that is somewhat bothersome; 3 = severe, intense itching that may interrupt daily activities and/or sleep
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
None 33 31 34 30
Mild 2 4 1 5
6.Secondary Outcome
Title Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Burning: 0 = none, no burning; 1 = mild, slight burning sensation, not really bothersome; 2 = moderate, definite warm, burning sensation that is somewhat bothersome; 3 = severe, hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
None 35 33 33 31
Mild 0 2 2 4
7.Secondary Outcome
Title Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Stinging: 0 = none, no stinging; 1 = mild, slight stinging sensation, not really bothersome; 2 = moderate, definite stinging sensation that is somewhat bothersome; 3 = severe, stinging sensation that causes definite discomfort and may interrupt daily activities and/or sleep
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
None 35 34 35 34
Mild 0 1 0 1
8.Secondary Outcome
Title Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness
Hide Description Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Tightness: 0 = none, no tightness; 1 = mild, slight tightness, not really bothersome; 2 = moderate, definite tightness sensation that is somewhat bothersome; 3 = severe, tightness sensation that causes definite discomfort and may interrupt daily activities and/or sleep
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3 Worst Post Baseline
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
Overall Number of Participants Analyzed 35 35 35 35
Measure Type: Number
Unit of Measure: participants
None 35 35 35 35
Mild 0 0 0 0
9.Secondary Outcome
Title Barrier Function (TEWL)
Hide Description Barrier function was assessed by measuring transepidermal water loss (TEWL) at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). TEWL measures water loss through the epidermis (for example, by evaporation). Measuring TEWL is a well-established way to assess the skin’s water-barrier function. High TEWL values indicate impaired skin barrier function; low values indicate normal barrier function.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days, TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 3.
Overall Number of Participants Analyzed 35 35 35
Mean (Standard Deviation)
Unit of Measure: g/m2/h
8.89  (3.01) 11.41  (5.22) 11.29  (3.25)
10.Secondary Outcome
Title Hydration (Corneometry)
Hide Description Hydration was assessed using corneometry at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Corneometry measures the hydration status of the skin. An increase in corneometry values indicates an increase in the hydration status of the skin, and vice versa. The test is procedure specific, so results are reported in "arbitrary units."
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Week 1 Week 3
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from baseline.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3.This arm shows the results from week 1.
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from week 3.
Overall Number of Participants Analyzed 35 35 35
Mean (Standard Deviation)
Unit of Measure: arbitrary units
55.75  (11.24) 56.51  (12.00) 48.28  (12.47)
11.Secondary Outcome
Title Subject Satisfaction Questionnaire - Face Wash
Hide Description All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title I Liked Using the Face Wash The Face Wash Was Easy to Use The Face Wash Made my Skin Feel Clean The Face Wash Rinsed Easily Off my Skin I Would Keep Using the Face Wash I Liked the Face Wash Better Than What I Was Using Before
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22). Subjects were only required to respond to this question if they had used a face wash previously.
Overall Number of Participants Analyzed 35 35 35 35 35 35
Measure Type: Number
Unit of Measure: participants
Yes 34 35 35 32 30 6
No 1 0 0 3 5 0
Missing 0 0 0 0 0 29
12.Secondary Outcome
Title Subject Satisfaction Questionnaire - Moisturizer
Hide Description All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title I Liked Using the Lotion The Lotion Smelled Good The Lotion Spread Easily on my Skin The Lotion Made my Skin Feel Soft I Would Keep Using the Lotion I Liked the Lotion Better Than What I Was Using Before
Hide Arm/Group Description:
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22). Subjects were only required to respond to this question if they had used a moisturizer previously.
Overall Number of Participants Analyzed 35 35 35 35 35 35
Measure Type: Number
Unit of Measure: participants
Yes 34 28 35 33 30 4
No 1 7 0 2 5 0
Missing 0 0 0 0 0 31
Time Frame There were 3 visits during the course of the study: visit 1(baseline/day1), visit 2 (day 8), and visit 3 (day 22/exit). Adverse event assessments were conducted for all subjects at every clinic visit after informed consent/assent was signed.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cetaphil® DermaControl™ Regimen.
Hide Arm/Group Description

All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.

Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30

All-Cause Mortality
Cetaphil® DermaControl™ Regimen.
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cetaphil® DermaControl™ Regimen.
Affected / at Risk (%) # Events
Total   0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cetaphil® DermaControl™ Regimen.
Affected / at Risk (%) # Events
Total   11/35 (31.43%)    
Gastrointestinal disorders   
Abdominal pain upper * 2  2/35 (5.71%)  2
Infections and infestations   
Impetigo * 2  1/35 (2.86%)  1
Injury, poisoning and procedural complications   
Contusion * 1  2/35 (5.71%)  2
Arthropod bite * 2  1/35 (2.86%)  1
Sunburn * 2  1/35 (2.86%)  1
Muscle strain * 2  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 2  1/35 (2.86%)  1
Skin and subcutaneous tissue disorders   
Skin burning sensation * 2  2/35 (5.71%)  2
Dermatitis contact * 2  1/35 (2.86%)  1
Pityriasis alba * 2  1/35 (2.86%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA (16.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth M Nieman
Organization: Galderma Laboratories, L.P.
Phone: 817-961-5130
EMail: elizabeth.nieman@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01909713     History of Changes
Other Study ID Numbers: GLI.04.SRE.04.US10245
First Submitted: July 1, 2013
First Posted: July 26, 2013
Results First Submitted: December 17, 2013
Results First Posted: March 24, 2014
Last Update Posted: March 24, 2014