RosaceaNCT03392558
The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea
A study testing Burt's Bees Skin Care Regimen in people with Rosacea, run by Burt's Bees Inc. at 1 site in United States.
Trial summary
This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct topical application to prescription medication when administered daily over the course of four weeks, in moderate to severe rosacea in comparison to the control regimen (CR). Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Rosacea
- What is being tested?
- Burt's Bees Skin Care Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be female 25-60 years of age with moderate facial rosacea at screening and 6 or 7 papules and/or pustules; as well as, no other known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant(R), Depo-Provera(R) double barrier methods (e.g., condom and spermacide) and abstinence.
- Subjects must provide written informed consent.
- Willingness to comply with the study design and procedures.
- Subjects who agree to sign a photography release form.
Who cannot join
- Any dermatological disorder, except rosacea requiring the use of prescription medication, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics,
- Subjects who are using any anti-aging skin care products within 4 weeks of study enrollment.
- Subjects who are not willing to use only the assigned study products and nothing else, except for self-selected colored cosmetics that must remain unchanged during the study, to their face.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Subjects, who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with clinically significant unstable medical disorders.
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- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- Subjects who have participated in any clinical study in the past 30 days or are currently participating in any other clinical study.
- Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
- Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day.
- Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork.
- Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, North Carolina, 27262
About this study
This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct topical application to prescription medication when administered daily over the course of four weeks, in moderate to severe rosacea in comparison to the control regimen (CR).
- Conditions
- Rosacea
- Being tested
- Burt's Bees Skin Care Regimen, Control Regimen
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burt's Bees Skin Care RegimenOther
Burt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime)
Control RegimenOther
Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily)
| Study group | Role | What they receive |
|---|---|---|
| Nature-Based Sensitive Skin Regimen | Experimental | Burt's Bees Skin Care Regimen (Nature Based Sensitive Skin Regimen, NBSSR):
1. Burt's Bees Sensitive Facial Cleanser (to be used day and night)
2. Burt's Bees Sensitive Daily Moisturizing Cream (to be used in the day)
3. Burt's Bees Sensitive Night Cream (to be used at night) Receives: Other: Burt's Bees Skin Care Regimen |
| Control Regimen | Active comparator | Control Skin Care Regimen (Control Regimen, CR):
1. Cetaphil Gentle Skin Cleanser (to be used day and night)
2. Cetaphil Moisturizing Lotion (to be used day and night) Receives: Other: Control Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment of Rosacea Scale Score
The primary efficacy endpoint is no increase in the cumulative Investigator Global Assessment of Rosacea Scale score, measured at Week 4 from baseline
Measured: 4 weeks
Secondary outcomes (1)
Overall Skin Quality
The secondary efficacy endpoint is at least no increase in the Overall Skin Quality domain of the Subject-Rated Efficacy Scale score, measured at Week 4 from baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Jan 2018
- Primary completion31 Mar 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burt's Bees Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Responsible party
- Sponsor
- Investigators
- Zoe D Draelos, MD, Principal investigator, Dermatology Consulting Services, High Point NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392558
- Sponsor's protocol ID
- DCS-25-17
- Status last verified
- Jun 2018
- First submitted
- 27 Dec 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Draelos ZD, Gunt H, Levy SB. Natural Skin Care Products as Adjunctive to Prescription Therapy in Moderate to Severe Rosacea. J Drugs Dermatol. 2019 Feb 1;18(2):141-146.
PubMed 30794364
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Suitability of Two Skin Care Regimens in Moderate to Severe Facial Rosacea
- ClinicalTrials.gov ID
- NCT03392558
- Acronym / sponsor ID
- DCS-25-17
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Burt's Bees Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Consulting Services, High Point NC
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a nature-based sensitive skin regimen (NBSSR), as a suitable adjunct topical application to prescription medication when administered daily over the course of four weeks, in moderate to severe rosacea in comparison to the control regimen (CR).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nature-Based Sensitive Skin Regimen | Experimental | Other: Burt's Bees Skin Care RegimenBurt's Bees Skin Care Regimen (Nature Based Sensitive Skin Regimen, NBSSR): 1. Burt's Bees Sensitive Facial Cleanser (to be used day and night) 2. Burt's Bees Sensitive Daily Moisturizing Cream (to be used in the day) 3. Burt's Bees Sensitive Night Cream (to be used at night) |
| Control Regimen | Active comparator | Other: Control RegimenControl Skin Care Regimen (Control Regimen, CR): 1. Cetaphil Gentle Skin Cleanser (to be used day and night) 2. Cetaphil Moisturizing Lotion (to be used day and night) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must be female 25-60 years of age with moderate facial rosacea at screening and 6 or 7 papules and/or pustules; as well as, no other known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant(R), Depo-Provera(R) double barrier methods (e.g., condom and spermacide) and abstinence.
- Subjects must provide written informed consent.
- Willingness to comply with the study design and procedures.
- Subjects who agree to sign a photography release form.
Key exclusion criteria (14 listed)
- Any dermatological disorder, except rosacea requiring the use of prescription medication, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics,
- Subjects who are using any anti-aging skin care products within 4 weeks of study enrollment.
- Subjects who are not willing to use only the assigned study products and nothing else, except for self-selected colored cosmetics that must remain unchanged during the study, to their face.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Subjects, who are pregnant, breast feeding, or planning a pregnancy.
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 |
|---|---|---|
| Burt's Bees Skin Care RegimenBurt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime) | Other | Nature-Based Sensitive Skin Regimen |
| Control RegimenCetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily) | Other | Control Regimen |
Primary outcome
Investigator Global Assessment of Rosacea Scale Score
Time frame: 4 weeks
The primary efficacy endpoint is no increase in the cumulative Investigator Global Assessment of Rosacea Scale score, measured at Week 4 from baseline
1 secondary outcome
Overall Skin Quality
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Derived from this study: PubMed 30794364Draelos ZD, Gunt H, Levy SB. Natural Skin Care Products as Adjunctive to Prescription Therapy in Moderate to Severe Rosacea. J Drugs Dermatol. 2019 Feb 1;18(2):141-146.
- Individual participant dataSharing planned: No
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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.
Zoe D Draelos, MD principal investigator
Dermatology Consulting Services, High Point NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burt's Bees Skin Care Regimen in people with Rosacea, run by Burt's Bees Inc. 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 5 inclusion and 14 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 21 Jun 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator Global Assessment of Rosacea Scale Score (time frame: 4 weeks). 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 NCT03392558, 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 21 Jun 2018.