Trial Outcomes & Findings for Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin. (NCT NCT01909713)
NCT ID: NCT01909713
Last Updated: 2022-08-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
Week 3
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Cetaphil® DermaControl™ Regimen.
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 Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
Baseline characteristics by cohort
| Measure |
Cetaphil® DermaControl™ Regimen.
n=35 Participants
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
|
|---|---|
|
Age, Continuous
|
9.0 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Age, Customized
|
9.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Normal Skin Type
|
35 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
II
|
7 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
III
|
5 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
IV
|
3 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
V
|
12 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
VI
|
8 participants
n=5 Participants
|
|
Global Severity of Acne
Clear
|
1 participants
n=5 Participants
|
|
Global Severity of Acne
Almost Clear
|
27 participants
n=5 Participants
|
|
Global Severity of Acne
MIld
|
7 participants
n=5 Participants
|
|
Oiliness Evaluation Score
Not Oily
|
28 participants
n=5 Participants
|
|
Oiliness Evaluation Score
Mildly Oily
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3Cutaneous 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.
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Visual Inspection - Erythema
None
|
29 participants
|
33 participants
|
30 participants
|
29 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Visual Inspection - Erythema
Very Mild
|
6 participants
|
2 participants
|
4 participants
|
5 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Visual Inspection - Erythema
Mild
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 3Cutaneous 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.
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Visual Inspection - Edema
None
|
35 participants
|
35 participants
|
34 participants
|
34 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Visual Inspection - Edema
Mild
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 3Cutaneous 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.
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Visual Inspection - Dryness
No Observable Scaling
|
34 participants
|
33 participants
|
32 participants
|
32 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Visual Inspection - Dryness
Fine Flakes/Scaling
|
1 participants
|
2 participants
|
3 participants
|
3 participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 3Cutaneous 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.
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Visual Inspection - Roughness
No Roughness, Skin is Fine, Silky Smooth
|
35 participants
|
34 participants
|
35 participants
|
34 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Visual Inspection - Roughness
Coarse, Rough Skin
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3Cutaneous 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
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching
None
|
33 participants
|
31 participants
|
34 participants
|
30 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching
Mild
|
2 participants
|
4 participants
|
1 participants
|
5 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3Cutaneous 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
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning
None
|
35 participants
|
33 participants
|
33 participants
|
31 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning
Mild
|
0 participants
|
2 participants
|
2 participants
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3Cutaneous 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
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging
None
|
35 participants
|
34 participants
|
35 participants
|
34 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging
Mild
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3Cutaneous 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
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness
None
|
35 participants
|
35 participants
|
35 participants
|
35 participants
|
—
|
—
|
|
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness
Mild
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3Barrier 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.
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post 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 worst post baseline results for all time ponts collected.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Barrier Function (TEWL)
|
8.89 g/m2/h
Standard Deviation 3.01
|
11.41 g/m2/h
Standard Deviation 5.22
|
11.29 g/m2/h
Standard Deviation 3.25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3Hydration 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."
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post 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 worst post baseline results for all time ponts collected.
|
I Would Keep Using the Face Wash
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).
|
I Liked the Face Wash Better Than What I Was Using Before
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.
|
|---|---|---|---|---|---|---|
|
Hydration (Corneometry)
|
55.75 arbitrary units
Standard Deviation 11.24
|
56.51 arbitrary units
Standard Deviation 12.00
|
48.28 arbitrary units
Standard Deviation 12.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22All 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).
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
n=35 Participants
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).
|
I Liked the Face Wash Better Than What I Was Using Before
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Subject Satisfaction Questionnaire - Face Wash
Yes
|
34 participants
|
35 participants
|
35 participants
|
32 participants
|
30 participants
|
6 participants
|
|
Subject Satisfaction Questionnaire - Face Wash
No
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
5 participants
|
0 participants
|
|
Subject Satisfaction Questionnaire - Face Wash
Missing
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Day 22All 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).
Outcome measures
| Measure |
Baseline
n=35 Participants
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.
|
Week 1
n=35 Participants
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.
|
Week 3
n=35 Participants
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.
|
Worst Post Baseline
n=35 Participants
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.
|
I Would Keep Using the Face Wash
n=35 Participants
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).
|
I Liked the Face Wash Better Than What I Was Using Before
n=35 Participants
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.
|
|---|---|---|---|---|---|---|
|
Subject Satisfaction Questionnaire - Moisturizer
Yes
|
34 participants
|
28 participants
|
35 participants
|
33 participants
|
30 participants
|
4 participants
|
|
Subject Satisfaction Questionnaire - Moisturizer
No
|
1 participants
|
7 participants
|
0 participants
|
2 participants
|
5 participants
|
0 participants
|
|
Subject Satisfaction Questionnaire - Moisturizer
Missing
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
31 participants
|
Adverse Events
Cetaphil® DermaControl™ Regimen.
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cetaphil® DermaControl™ Regimen.
n=35 participants at risk
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
|
|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
2/35 • Number of events 2 • 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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.9%
1/35 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Sunburn
|
2.9%
1/35 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
2.9%
1/35 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
5.7%
2/35 • Number of events 2 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.9%
1/35 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
2.9%
1/35 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.7%
2/35 • Number of events 2 • 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.
|
|
Infections and infestations
Impetigo
|
2.9%
1/35 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60