Acne Prone SkinPhase 4NCT01909713
Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
A Phase 4 study testing Facial Cleanser and Moisturizer SPF 30 in people with Acne Prone Skin, run by Galderma R&D at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Acne Prone Skin
- What is being tested?
- Facial Cleanser and Moisturizer SPF 30
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects 7-11 years of age
- Subjects with acne-prone skin [Global severity of acne (GSA) Score of 1 (almost clear) or 2 (mild) and any oiliness evaluation score or GSA Score of 0 (none) with an oiliness evaluation score greater than or equal to 1 (mild)]
Who cannot join
- Subjects with any visible skin condition or facial hair that could interfere with the evaluations
- Subjects taking other medications, supplements, or non-prescription treatments that, in the opinion of the principal investigator/board certified dermatologist, could interfere with the test results including any regimen of steroidal/non steroidal anti-inflammatory drugs or antihistamines
- Subjects currently under the treatment for asthma or diabetes (insulin-dependent only)
- Subjects with abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or body art (tattoos, permanent or temporary) on the face, which could interfere with subsequent evaluations of dermal responsiveness
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Acne Prone Skin
- Being tested
- Facial Cleanser and Moisturizer SPF 30
- Keywords
- acne, pediatric
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Cleanser and Moisturizer SPF 30Drug
Also called Cetaphil® DermaControl™ skin care products
Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Facial Cleanser and Moisturizer SPF 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 3
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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."
Measured: 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).
Measured: 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).
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne Prone SkinStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warren Winkelman, MD, MBA, PhD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909713
- Sponsor's protocol ID
- GLI.04.SRE.04.US10245
- Status last verified
- Dec 2013
- First submitted
- 1 Jul 2013
- Last updated
- 23 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25973678
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
- ClinicalTrials.gov ID
- NCT01909713
- Acronym / sponsor ID
- GLI.04.SRE.04.US10245
- Conditions
- Acne Prone Skin
- Keywords
- acne, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Posted 24 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial Cleanser and Moisturizer SPF 30 | Experimental | Drug: Facial Cleanser and Moisturizer SPF 30All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female subjects 7-11 years of age
- Subjects with acne-prone skin [Global severity of acne (GSA) Score of 1 (almost clear) or 2 (mild) and any oiliness evaluation score or GSA Score of 0 (none) with an oiliness evaluation score greater than or equal to 1 (mild)]
Key exclusion criteria (4 listed)
- Subjects with any visible skin condition or facial hair that could interfere with the evaluations
- Subjects taking other medications, supplements, or non-prescription treatments that, in the opinion of the principal investigator/board certified dermatologist, could interfere with the test results including any regimen of steroidal/non steroidal anti-inflammatory drugs or antihistamines
- Subjects currently under the treatment for asthma or diabetes (insulin-dependent only)
- Subjects with abnormal pigmented vascular skin lesions, abnormal skin pigmentation, or body art (tattoos, permanent or temporary) on the face, which could interfere with subsequent evaluations of dermal responsiveness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial Cleanser and Moisturizer SPF 30Also: Cetaphil® DermaControl™ skin care productsCetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 | Drug | Facial Cleanser and Moisturizer SPF 30 |
Primary outcome
Cutaneous Tolerability Based on Visual Inspection - Erythema
Time frame: Week 3
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.
Cutaneous Tolerability Based on Visual Inspection - Edema
Time frame: Week 3
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.
Cutaneous Tolerability Based on Visual Inspection - Dryness
Time frame: Week 3
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.
Cutaneous Tolerability Based on Visual Inspection - Roughness
Time frame: Week 3
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.
8 secondary outcomes
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching
Time frame: Week 3
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning
Time frame: Week 3
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging
Time frame: Week 3
Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness
Time frame: Week 3
Barrier Function (TEWL)
Time frame: Week 3
Hydration (Corneometry)
Time frame: Week 3
Subject Satisfaction Questionnaire - Face Wash
Time frame: Day 22
Subject Satisfaction Questionnaire - Moisturizer
Time frame: Day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25973678Hensley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Winkelman, MD, MBA, PhD study director
Galderma R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Facial Cleanser and Moisturizer SPF 30 in people with Acne Prone Skin, run by Galderma R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous Tolerability Based on Visual Inspection - Erythema (time frame: Week 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01909713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.