Acne VulgarisPhase 1NCT01112787
A Study to Evaluate the Irritation Potential of Tazarotene Foam on Skin in Healthy Volunteers
A Phase 1 study testing Tazarotene Foam, Sodium Laural Sulfate and Distilled Water in people with Acne Vulgaris, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the irritation level of tazarotene foam after 21 days of exposure on the skin of healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Tazarotene Foam, Sodium Laural Sulfate and Distilled Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2010to 26 Apr 2010
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable of understanding and willing to provide signed and dated written voluntary informed consent and Health Information Portability and Accountability Act (HIPAA) authorization before any protocol-specific procedures are performed.
- Male or female aged 18 to 65 years, inclusive, at time of consent.
- Able and willing to complete the study and to comply with all study instructions.
- Possess Fitzpatrick skin types I (always burns easily; never tans), II (always burns easily; tans minimally), III (burns moderately; tans gradually), or IV (rarely burns; tans with ease) that will not interfere with the evaluation of any skin responses .
- Male subjects and their partners must agree to use a medically acceptable method of contraception.
- Additional criteria for women of childbearing potential, defined as one who is biologically capable of becoming pregnant, including perimenopausal women who are less than 2 years from their last menses:
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- A regular menstrual cycle before study entry (as reported by the subject).
- Negative urine pregnancy test within 2 weeks of the first application of study product.
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception throughout the duration of the study.
- Women who are not currently sexually active must agree to use a medically acceptable method of contraception should they become sexually active while participating in the study.
Who cannot join
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Considered unable or unlikely to attend the necessary visits.
- History of known or suspected intolerance to tazarotene, any of the ingredients of the study products, the hypoallergenic tape, or the cotton patches.
- Participation in any patch test study within 4 weeks of the Day 1 visit.
- Inability to evaluate the skin in and around the potential patch test sites on the back due to sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
- Clinically significant skin diseases that may contraindicate participation or interfere with patch test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer.
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- Any major illness within 4 weeks of the Day 1 visit.
- Considered immunocompromised.
- A clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- Clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
- Received any investigational product or procedure within 4 weeks of the Day 1 visit or who is scheduled to receive an investigational product (other than the study product) or procedure during the study.
- Received allergy injections within 1 week of the Day 1 visit, or expects to receive allergy injections during study participation.
- Received immunizations within 4 weeks of the Day 1 visit.
- Used systemic or topical corticosteroids or other immunosuppressive medications within 4 weeks of the Day 1 visit.
- Used topical medications or other products (eg, self tanning products, waxing products, benzoyl peroxide, salicylic acid, or sulfur) in the areas of patch testing within 2 weeks of the Day 1 visit.
- Used antihistamines, selective leukotriene receptor antagonists (eg, montelukast sodium, zafirlukast), or mast cell stabilizers (eg, cromolyn sodium or nedocromil sodium) within 4 weeks of the Day 1 visit.
- Used nonsteroidal anti-inflammatory medications within 2 weeks of the Day 1 visit.
- Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
- Participated in a previous study of the same study product.
- Employee of the study center, contract research organization, or Stiefel who is involved in the study, or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee who is involved in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
HillTop Research Corporation
Scottsdale, Arizona, 85251
About this study
Official title: A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Cumulative Irritation Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
The purpose of this study is to evaluate the irritation level of tazarotene foam after 21 days of exposure on the skin of healthy volunteers.
Read the detailed description
This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to evaluate the potential of tazarotene foam to induce cutaneous irritation using a 21 day cumulative irritation assay in healthy adult volunteers. Approximately 40 healthy male and female volunteer subjects aged 18 to 65 years will be enrolled. All subjects will be exposed to patches containing tazarotene foam, vehicle foam, sodium lauryl sulfate 0.5% (positive control), and distilled water (negative control). Each set of patches will be applied to the same randomized sites once daily for 21 days; patches will be removed after 24 ±1 hours and the patch sites will be evaluated for signs inflammatory skin responses (eg, erythema, edema, papules) and superficial effects.
- Conditions
- Acne Vulgaris
- Being tested
- Tazarotene Foam, Vehicle Foam, Sodium Laural Sulfate, Distilled Water
- Keywords
- Healthy Volunteer Subjects
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tazarotene FoamDrug
Tazarotene Foam
Vehicle FoamDrug
Vehicle Foam
Sodium Laural SulfateDrug
Sodium Laural Sulfate
Distilled WaterDrug
Distilled Water
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene Foam | Experimental | Subjects will be exposed to patches containing Tazarotene Foam 0.1%, Receives: Drug: Tazarotene Foam |
| Vehicle Foam | Placebo comparator | Subjects will be exposed to patches containing Vehicle Foam. Receives: Drug: Vehicle Foam |
| Sodium Laural Sulfate | Active comparator | Subjects will be exposed to patches containing Sodium Laural Sulfate. Receives: Drug: Sodium Laural Sulfate |
| Distilled Water | Placebo comparator | Subjects will be exposed to patches containing Distilled Water. Receives: Drug: Distilled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory skin responses
Patch sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study start26 Mar 2010
- Primary completion26 Apr 2010
- Study completion26 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112787
- Sponsor's protocol ID
- 114571
- Status last verified
- Jun 2017
- First submitted
- 27 Apr 2010
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Cumulative Irritation Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01112787
- Acronym / sponsor ID
- 114571
- Conditions
- Acne Vulgaris
- Keywords
- Healthy Volunteer Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 26 Mar 2010 (actual)
- Primary completion
- 26 Apr 2010 (actual)
- Study completion
- 26 Apr 2010 (actual)
- First posted
- 28 Apr 2010 (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.
The purpose of this study is to evaluate the irritation level of tazarotene foam after 21 days of exposure on the skin of healthy volunteers.
Detailed description
This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to evaluate the potential of tazarotene foam to induce cutaneous irritation using a 21 day cumulative irritation assay in healthy adult volunteers. Approximately 40 healthy male and female volunteer subjects aged 18 to 65 years will be enrolled. All subjects will be exposed to patches containing tazarotene foam, vehicle foam, sodium lauryl sulfate 0.5% (positive control), and distilled water (negative control). Each set of patches will be applied to the same randomized sites once daily for 21 days; patches will be removed after 24 ±1 hours and the patch sites will be evaluated for signs inflammatory skin responses (eg, erythema, edema, papules) and superficial effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tazarotene Foam | Experimental | Drug: Tazarotene FoamSubjects will be exposed to patches containing Tazarotene Foam 0.1%, |
| Vehicle Foam | Placebo comparator | Drug: Vehicle FoamSubjects will be exposed to patches containing Vehicle Foam. |
| Sodium Laural Sulfate | Active comparator | Drug: Sodium Laural SulfateSubjects will be exposed to patches containing Sodium Laural Sulfate. |
| Distilled Water | Placebo comparator | Drug: Distilled WaterSubjects will be exposed to patches containing Distilled Water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Capable of understanding and willing to provide signed and dated written voluntary informed consent and Health Information Portability and Accountability Act (HIPAA) authorization before any protocol-specific procedures are performed.
- Male or female aged 18 to 65 years, inclusive, at time of consent.
- Able and willing to complete the study and to comply with all study instructions.
- Possess Fitzpatrick skin types I (always burns easily; never tans), II (always burns easily; tans minimally), III (burns moderately; tans gradually), or IV (rarely burns; tans with ease) that will not interfere with the evaluation of any skin responses .
- Male subjects and their partners must agree to use a medically acceptable method of contraception.
Key exclusion criteria (20 listed)
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Considered unable or unlikely to attend the necessary visits.
- History of known or suspected intolerance to tazarotene, any of the ingredients of the study products, the hypoallergenic tape, or the cotton patches.
- Participation in any patch test study within 4 weeks of the Day 1 visit.
- Inability to evaluate the skin in and around the potential patch test sites on the back due to sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
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 |
|---|---|---|
| Tazarotene FoamTazarotene Foam | Drug | Tazarotene Foam |
| Vehicle FoamVehicle Foam | Drug | Vehicle Foam |
| Sodium Laural SulfateSodium Laural Sulfate | Drug | Sodium Laural Sulfate |
| Distilled WaterDistilled Water | Drug | Distilled Water |
Primary outcome
Inflammatory skin responses
Time frame: 21 days
Patch sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.
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 20 Jun 2017.
- Results for study 114571 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tazarotene Foam, Sodium Laural Sulfate and Distilled Water in people with Acne Vulgaris, run by Stiefel, a GSK Company 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 10 inclusion and 20 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 20 Jun 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Inflammatory skin responses (time frame: 21 days). 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 20 Jun 2017.