Sun-Damaged SkinNCT00440024
The Effect Of A Controlled Daily Skin Care Regimen On Retinoic Acid Tolerance
A study testing Tazorac, Dove Mild Cleanser and Dove Facial Moisturizer in people with Sun-Damaged Skin and Retinoid Intolerance, run by University of Michigan at 1 site in United States.
Trial summary
Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by features such as wrinkling, uneven skin color, roughness and brown spots. An effective treatment for sun-damage that is commonly prescribed is topical retinoic acid (RA). Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sun-Damaged Skin, Retinoid Intolerance
- What is being tested?
- Tazorac, Dove Mild Cleanser and Dove Facial Moisturizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Nov 2009
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasians between the ages of 40 and 90 with moderate to severe sun-damage on the face who are generally healthy may participate.
- You must demonstrate a previous history of retinoid intolerance (established through prior history and the 2-week retinoid treatment phase of this study).
- Women of childbearing potential must agree to use an accepted form of birth control for the entire duration of the study.
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Who cannot join
- You may not have used any topical or systemic retinoids in the past 6 months.
- Women who are pregnant or nursing may not participate.
- If you have a history of non-melanoma skin cancer on the face in the past 5 years, you may not participate.
- If you have any history of malignant melanoma you may not participate.
- If you have any other skin condition or facial hair that will interfere with the study evaluations, you may not participate.
- If you have a known sensitivity to any of the ingredients in the study cream or Dove products, you may not participate.
- If you are currently on special daily skin care regimens that include cleansing with Dove, Olay, Aveeno or Cetaphil liquid facial cleansers and using facial moisturizers more than twice a day you may not participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
Official title: A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients (Derm 570)
Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by features such as wrinkling, uneven skin color, roughness and brown spots. An effective treatment for sun-damage that is commonly prescribed is topical retinoic acid (RA). However, the major drawback of topical RA use has been frequently observed irritation characterized by redness, dry skin and severe itching. In this study, we examine whether a daily skin care regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve tolerance to RA treatment.
Read the detailed description
Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by features such as wrinkling, uneven skin color, roughness and brown spots. An effective treatment for sun-damage that is commonly prescribed is topical retinoic acid. However, the major drawback of topical retinoic acid use has been frequently observed irritation characterized by redness, dry skin and severe itching. In this study, we examine whether a daily skin care regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve tolerance to retinoid treatment.
Subjects for whom retinoid treatment is indicated for sun-damage will be recruited into the study. The retinoid intolerance will be established via prior history (detailed questionnaire) and a 2-week retinoid treatment (Tazarotene 0.1% cream) phase followed by clinical evaluation and determination of retinoid intolerance.
Subjects that exhibit retinoid intolerance will continue with the study. Approximately 30 subjects will be put on a controlled daily skin care regimen during the remainder of the study period while the rest of the subjects will continue their normal skin care habits. The controlled skin care regimen will consist of facial cleansing with a Dove ultra mild emollient cleanser and application of Dove facial moisturizer, used as normal. During this period, subjects will be evaluated to determine reduction of retinoid intolerance symptoms.
- Conditions
- Sun-Damaged Skin, Retinoid Intolerance
- Being tested
- Tazorac, Dove Mild Cleanser, Dove Facial Moisturizer
- Keywords
- Sun-Damaged Skin, Retinoid Intolerance, Tazarotene Cream, Dove facial cleanser, Dove moisturizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazoracDrug
Also called Tazarotene
Tazarotene 0.1% cream applied to the face once daily before bed
Dove Mild CleanserDrug
Also called Dove Non-foaming Cleanser
Ultra mild cleanser: Dove Non-foaming cleansing lotion
Dove Facial MoisturizerDrug
Moisturizing cream - Dove facial moisturizer with SPF 15
| Study group | Role | What they receive |
|---|---|---|
| Cell A | Experimental | Study controlled daily skin care regimen during 'rest period' consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac Receives: Drug: Tazorac; Drug: Dove Mild Cleanser; Drug: Dove Facial Moisturizer |
| Cell B | Placebo comparator | Subject controlled normal skin care regimen during 'rest period, followed by study controlled daily skin care regime consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac Receives: Drug: Tazorac; Drug: Dove Mild Cleanser; Drug: Dove Facial Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinoid irritation symptoms
Measured: Weeks 6, 8, 12, 16, 20 and 24
Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots).
Measured: At the end of the study (week 24)
Secondary outcomes (1)
Treatment effects, such as erythema, peeling, itching, and burning/stinging will be evaluated at each study visit.
Measured: Weeks 6, 8, 12, 16, 20 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sun-Damaged SkinStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Principal investigator, Dana L. Sachs, MD, University of Michigan
- Investigators
- Dana Sachs, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440024
- Sponsor's protocol ID
- Derm 570
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2007
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind Study to Assess Benefits of a Controlled Daily Skin Care Regimen on Retinoid Intolerant Patients (Derm 570)
- ClinicalTrials.gov ID
- NCT00440024
- Acronym / sponsor ID
- Derm 570
- Conditions
- Sun-Damaged Skin, Retinoid Intolerance
- Keywords
- Sun-Damaged Skin, Retinoid Intolerance, Tazarotene Cream, Dove facial cleanser, Dove moisturizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Feb 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 Feb 2007 (estimated)
- 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.
Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by features such as wrinkling, uneven skin color, roughness and brown spots. An effective treatment for sun-damage that is commonly prescribed is topical retinoic acid (RA). However, the major drawback of topical RA use has been frequently observed irritation characterized by redness, dry skin and severe itching. In this study, we examine whether a daily skin care regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve tolerance to RA treatment.
Detailed description
Sun-damaged skin, caused by chronic exposure to ultraviolet (UV) light, is characterized by features such as wrinkling, uneven skin color, roughness and brown spots. An effective treatment for sun-damage that is commonly prescribed is topical retinoic acid. However, the major drawback of topical retinoic acid use has been frequently observed irritation characterized by redness, dry skin and severe itching. In this study, we examine whether a daily skin care regimen comprised of an ultra mild cleanser and an effective moisturizer can help improve tolerance to retinoid treatment.
Subjects for whom retinoid treatment is indicated for sun-damage will be recruited into the study. The retinoid intolerance will be established via prior history (detailed questionnaire) and a 2-week retinoid treatment (Tazarotene 0.1% cream) phase followed by clinical evaluation and determination of retinoid intolerance.
Subjects that exhibit retinoid intolerance will continue with the study. Approximately 30 subjects will be put on a controlled daily skin care regimen during the remainder of the study period while the rest of the subjects will continue their normal skin care habits. The controlled skin care regimen will consist of facial cleansing with a Dove ultra mild emollient cleanser and application of Dove facial moisturizer, used as normal. During this period, subjects will be evaluated to determine reduction of retinoid intolerance symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell A | Experimental | Drug: Tazorac, Drug: Dove Mild Cleanser, Drug: Dove Facial MoisturizerStudy controlled daily skin care regimen during 'rest period' consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac |
| Cell B | Placebo comparator | Drug: Tazorac, Drug: Dove Mild Cleanser, Drug: Dove Facial MoisturizerSubject controlled normal skin care regimen during 'rest period, followed by study controlled daily skin care regime consisting of Dove Mild Cleanser, Dove Facial Moisturizer with SPF 15 followed by Tazorac |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasians between the ages of 40 and 90 with moderate to severe sun-damage on the face who are generally healthy may participate.
- You must demonstrate a previous history of retinoid intolerance (established through prior history and the 2-week retinoid treatment phase of this study).
- Women of childbearing potential must agree to use an accepted form of birth control for the entire duration of the study.
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Key exclusion criteria (7 listed)
- You may not have used any topical or systemic retinoids in the past 6 months.
- Women who are pregnant or nursing may not participate.
- If you have a history of non-melanoma skin cancer on the face in the past 5 years, you may not participate.
- If you have any history of malignant melanoma you may not participate.
- If you have any other skin condition or facial hair that will interfere with the study evaluations, you may not participate.
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 |
|---|---|---|
| TazoracAlso: TazaroteneTazarotene 0.1% cream applied to the face once daily before bed | Drug | Cell A, Cell B |
| Dove Mild CleanserAlso: Dove Non-foaming CleanserUltra mild cleanser: Dove Non-foaming cleansing lotion | Drug | Cell A, Cell B |
| Dove Facial MoisturizerMoisturizing cream - Dove facial moisturizer with SPF 15 | Drug | Cell A, Cell B |
Primary outcome
Retinoid irritation symptoms
Time frame: Weeks 6, 8, 12, 16, 20 and 24
Improvement of sun-damage (wrinkling, uneven skin color, roughness and brown spots).
Time frame: At the end of the study (week 24)
1 secondary outcome
Treatment effects, such as erythema, peeling, itching, and burning/stinging will be evaluated at each study visit.
Time frame: Weeks 6, 8, 12, 16, 20 and 24
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 13 Mar 2020.
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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.
Dana Sachs, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tazorac, Dove Mild Cleanser and Dove Facial Moisturizer in people with Sun-Damaged Skin and Retinoid Intolerance, run by University of Michigan 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 4 inclusion and 7 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 13 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
Retinoid irritation symptoms (time frame: Weeks 6, 8, 12, 16, 20 and 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2020.