Acne VulgarisPhase 1NCT01119651
A Study to Evaluate the Potential of Tazarotene Foam to Cause an Allergic Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers.
A Phase 1 study testing Tazarotene (Patch application in Challenge Phase) 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 potential of Tazarotene Foam to induce a photoallergic reaction when exposed to UV and VIS light on 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 (Patch application in Challenge Phase)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2010to 26 Jun 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), or III (burns moderately; tans gradually) that will not interfere with the evaluation of any skin responses (Fitzpatrick 1988). Determination of skin types will be based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
- 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. Acceptable contraceptive methods include the following:
- Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.
- Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth vaginally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermicide is acceptable.
- 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 Screening Visit 1.
- 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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- A history of severe reactions from exposure to sunlight, including previous experience with photoallergy, solar urticaria, polymorphous light eruptions, or other photo exacerbated systemic diseases.
- Any major illness within 4 weeks of Screening Visit 1.
- 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.
- Used photosensitizing medications (prescription, nonprescription, or herbal) or a known photosensitizing material within 2 weeks of Screening Visit 1.
- Received any investigational product or procedure within 4 weeks of Screening Visit 1 or is scheduled to receive an investigational product (other than the study product) or procedure during the study.
- Received allergy injections within 1 week of Screening Visit 1, or expects to receive allergy injections during study participation.
- Received immunizations within 4 weeks of Screening Visit 1.
- Used systemic or topical corticosteroids or other immunosuppressive medications within 4 weeks of Screening Visit 1.
- 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 Screening Visit 1.
- Used antihistamines, selective leukotriene receptor antagonists (eg, montelukast sodium, zafirlukast), or mast cell stabilizers (eg, cromolyn sodium or nedocromil sodium) within 4 weeks of Screening Visit 1.
- Used nonsteroidal anti inflammatory medications within 2 weeks of Screening Visit 1.
- 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
St. Petersburg, Florida, 33710
About this study
Official title: A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Photoallergic Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a photoallergic reaction when exposed to UV and VIS light on 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 0.1% to induce a photoallergic reaction in healthy adult volunteers. Approximately 62 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, and no foam (blank; negative control). Inflammatory skin responses (eg, erythema and local skin reactions) or superficial effects at patch sites will be visually assessed to corresponding grading scales. The study duration will be 6 weeks or 9 weeks and will consist of the following phases: Screening, 3 week Induction, 2 week Rest, and 1 week Challenge, and if indicated, a second 2 week Rest and 1 week Repeat Challenge.
- Conditions
- Acne Vulgaris
- Being tested
- Tazarotene (Patch application in Challenge Phase)
- 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 (Patch application in Challenge Phase)Drug
There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated \& will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E.
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene Foam without irradiation | Experimental | Subjects will be exposed to Tazarotene Foam Patch without irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Tazarotene Foam with UVA and UVB irradiation | Experimental | Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Tazarotene Foam & UVA/UVB/visible light | Experimental | Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB and visible light irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Vehicle Foam without irradiation, | Placebo comparator | Subjects will be exposed to Vehicle Foam Patch without irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Vehicle Foam with UVA and UVB irradiation | Placebo comparator | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Vehicle Foam with UVA & UVB visible light irradiation | Placebo comparator | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Blank patch without irradiation | Sham comparator | Subjects will be exposed to blank patch without irradiation, Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Blank patch with UVA and UVB irradiation | Sham comparator | Subjects will be exposed to blank patch with UVA and UVB irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
| Blank Patch with UVA & UVB visible light irradiation | Sham comparator | Subjects will be exposed to Blank Patch with UVA and UVB and visible light irradiation Receives: Drug: Tazarotene (Patch application in Challenge Phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory skin responses
Patch site evaluations for signs of inflammatory skin responses and superficial effect
Measured: 54 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study start14 Jun 2010
- Primary completion26 Jun 2010
- Study completion26 Jun 2010
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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 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
- NCT01119651
- Sponsor's protocol ID
- 114574
- Status last verified
- Jun 2017
- First submitted
- 5 May 2010
- Last updated
- 14 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.
Publications
Hogan DJ, Saenz AB. Phototoxic and photoallergic potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Cutis. 2012 Nov;90(5):266-71.
PubMed 23270200
Study at a glance
From the registry record, last updated by the sponsor on 14 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 Photoallergic Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01119651
- Acronym / sponsor ID
- 114574
- Conditions
- Acne Vulgaris
- Keywords
- Healthy Volunteer Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 14 Jun 2010 (actual)
- Primary completion
- 26 Jun 2010 (actual)
- Study completion
- 26 Jun 2010 (actual)
- First posted
- 7 May 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 potential of Tazarotene Foam to induce a photoallergic reaction when exposed to UV and VIS light on 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 0.1% to induce a photoallergic reaction in healthy adult volunteers. Approximately 62 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, and no foam (blank; negative control). Inflammatory skin responses (eg, erythema and local skin reactions) or superficial effects at patch sites will be visually assessed to corresponding grading scales. The study duration will be 6 weeks or 9 weeks and will consist of the following phases: Screening, 3 week Induction, 2 week Rest, and 1 week Challenge, and if indicated, a second 2 week Rest and 1 week Repeat Challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Tazarotene Foam without irradiation | Experimental | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to Tazarotene Foam Patch without irradiation |
| Tazarotene Foam with UVA and UVB irradiation | Experimental | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation |
| Tazarotene Foam & UVA/UVB/visible light | Experimental | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB and visible light irradiation |
| Vehicle Foam without irradiation, | Placebo comparator | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to Vehicle Foam Patch without irradiation |
| Vehicle Foam with UVA and UVB irradiation | Placebo comparator | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation |
| Vehicle Foam with UVA & UVB visible light irradiation | Placebo comparator | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation |
| Blank patch without irradiation | Sham comparator | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to blank patch without irradiation, |
| Blank patch with UVA and UVB irradiation | Sham comparator | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to blank patch with UVA and UVB irradiation |
| Blank Patch with UVA & UVB visible light irradiation | Sham comparator | Drug: Tazarotene (Patch application in Challenge Phase)Subjects will be exposed to Blank Patch with UVA and UVB and visible light irradiation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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), or III (burns moderately; tans gradually) that will not interfere with the evaluation of any skin responses (Fitzpatrick 1988). Determination of skin types will be based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
- Male subjects and their partners must agree to use a medically acceptable method of contraception.
Key exclusion criteria (22 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 Screening Visit 1.
- 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 (Patch application in Challenge Phase)There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated \& will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E. | Drug | Blank Patch with UVA & UVB visible light irradiation, Blank patch with UVA and UVB irradiation, Blank patch without irradiation, Tazarotene Foam & UVA/UVB/visible light, Tazarotene Foam with UVA and UVB irradiation, Tazarotene Foam without irradiation, Vehicle Foam with UVA & UVB visible light irradiation, Vehicle Foam with UVA and UVB irradiation, Vehicle Foam without irradiation, |
Primary outcome
Inflammatory skin responses
Time frame: 54 days
Patch site evaluations for signs of inflammatory skin responses and superficial effect
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 14 Jun 2017.
- Background: PubMed 23270200Hogan DJ, Saenz AB. Phototoxic and photoallergic potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Cutis. 2012 Nov;90(5):266-71.
- Results for study 114574 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 (Patch application in Challenge Phase) 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 12 inclusion and 22 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 14 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: 54 days). 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 NCT01119651, 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 14 Jun 2017.