Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.
This was a open-label, single center study conducted in the United States that evaluated the tolerability of Cetaphil® DermaControl™ skin care products used at least once daily for 22 days in male and female subjects age 7 to 11 with acne prone skin. There were 4 visits during the course of the study: screening (within 7 days of visit 1), visit 1(baseline /day1), visit 2 (day 8), and visit 3 (day 22/exit). Tolerability assessments were performed by a board certified dermatologist at all visits. Subjects completed the baseline skin care regimen questionnaire at visit 1. Hydration assessments were competed at visits 1, 2, and 3. A subject satisfaction questionnaire was completed at visit 3. Adverse event assessments were conducted for all subjects at every clinic visit after informed consent/assent was signed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial Cleanser and Moisturizer SPF 30 | Experimental | All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial Cleanser and Moisturizer SPF 30 | Drug | Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous Tolerability Based on Visual Inspection - Erythema | 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. | Week 3 |
| Cutaneous Tolerability Based on Visual Inspection - Edema | 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. | Week 3 |
| Cutaneous Tolerability Based on Visual Inspection - Dryness | 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. | Week 3 |
| Cutaneous Tolerability Based on Visual Inspection - Roughness | 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. | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Warren Winkelman, MD, MBA, PhD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RCTS, Inc. | Irving | Texas | 75062 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25973678 | Derived | Hensley D, Meckfessel MH. Tolerability of a Skin Care Regimen Formulated for Acne-Prone Skin in Children. Pediatr Dermatol. 2015 Jul-Aug;32(4):501-5. doi: 10.1111/pde.12607. Epub 2015 May 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cutaneous Tolerability Based on Visual Inspection - Erythema | 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. | Posted | Number | participants | Week 3 |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M Nieman | Galderma Laboratories, L.P. | 817-961-5130 | elizabeth.nieman@galderma.com |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 3 |
| Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning | 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 | Week 3 |
| Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging | 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 | Week 3 |
| Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness | 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 | Week 3 |
| Barrier Function (TEWL) | 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. | Week 3 |
| Hydration (Corneometry) | 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." | Week 3 |
| Subject Satisfaction Questionnaire - 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). | Day 22 |
| Subject Satisfaction Questionnaire - Moisturizer | 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). | Day 22 |
| years |
|
| Age, Customized | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Normal Skin Type | Number | participants |
|
| Fitzpatrick Skin Type | 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 | Number | participants |
|
| Global Severity of Acne | Number | participants |
|
| Oiliness Evaluation Score | Number | 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.
| OG002 | 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 results from week 3. |
| OG003 | 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. |
|
|
| Secondary | Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching | 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 | Posted | Number | participants | Week 3 |
|
|
|
| Primary | Cutaneous Tolerability Based on Visual Inspection - Edema | 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. | Posted | Number | participants | Week 3 |
|
|
|
| Primary | Cutaneous Tolerability Based on Visual Inspection - Dryness | 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. | Posted | Number | participants | Week 3 |
|
|
|
| Primary | Cutaneous Tolerability Based on Visual Inspection - Roughness | 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. | Posted | Number | participants | Week 3 |
|
|
|
| Secondary | Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning | 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 | Posted | Number | participants | Week 3 |
|
|
|
| Secondary | Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging | 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 | Posted | Number | participants | Week 3 |
|
|
|
| Secondary | Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness | 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 | Posted | Number | participants | Week 3 |
|
|
|
| Secondary | Barrier Function (TEWL) | 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. | Posted | Mean | Standard Deviation | g/m2/h | Week 3 |
|
|
|
| Secondary | Hydration (Corneometry) | 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." | Posted | Mean | Standard Deviation | arbitrary units | Week 3 |
|
|
|
| Secondary | Subject Satisfaction Questionnaire - 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). | Posted | Number | participants | Day 22 |
|
|
|
| Secondary | Subject Satisfaction Questionnaire - Moisturizer | 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). | Posted | Number | participants | Day 22 |
|
|
|
| 0 |
| 35 |
| 11 |
| 35 |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pityriasis alba | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
Not provided
| Mild |
|
| Mild |
|
| Fine Flakes/Scaling |
|
| Coarse, Rough Skin |
|
| Mild |
|
| Mild |
|
| Mild |
|
| No |
|
| Missing |
|
| No |
|
| Missing |
|