Acne VulgarisPhase 1NCT01115322
A Study to Evaluate the Potential of Tazarotene Foam to Cause a Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers
A Phase 1 study testing Tazarotene Foam without irradiation, Tazarotene Foam with UVA and UVB irradiation and Tazarotene Foam with UVA, UVB, and visible light 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 phototoxic 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 Foam without irradiation, Tazarotene Foam with UVA and UVB irradiation and Tazarotene Foam with UVA, UVB, and visible light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2010to 10 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), 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
Scottsdale, Arizona, 85251
About this study
Official title: A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled Study To Evaluate The Phototoxic 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 phototoxic 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 phototoxic reaction in healthy adult volunteers. Approximately 40 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.
Each subject will be exposed to three (3) sets of three (3) patches containing Tazarotene Foam, Vehicle Foam and a Blank Patch (no study product). Each patch set will be applied to randomized sites on the subject's back. Patch sets will be removed and evaluated after 24 hours of exposure. The exposed patch sites will then be irradiated (exposed to light) and evaluated at 1 hour post irradiation and at 24, 48, and 72 hours.
- Conditions
- Acne Vulgaris
- Being tested
- Tazarotene Foam without irradiation, Tazarotene Foam with UVA and UVB irradiation, Tazarotene Foam with UVA, UVB, and visible light, Vehicle Foam without irradiation, Vehicle Foam with UVA and UVB irradiation
- Keywords
- Healthy volunteer study, phototoxicity
- Medical subject headings
- Acne Vulgaris, Dermatitis, Phototoxic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tazarotene Foam without irradiationDrug
Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period.
This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Tazarotene Foam with UVA and UVB irradiationDrug
Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Tazarotene Foam with UVA, UVB, and visible lightDrug
Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Vehicle Foam without irradiationDrug
Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Vehicle Foam with UVA and UVB irradiationDrug
Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Vehicle Foam with UVA and UVB and visible light irradiationDrug
Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
No Treatment without irradiationDrug
Each subject will be exposed to a blank patch during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
No Treatment with UVA and UVB irradiationDrug
Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
No Treatment with UVA and UVB and visible light irradiationDrug
Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
| Study group | Role | What they receive |
|---|---|---|
| Tazarotene Foam without irradiation | Experimental | Subjects will be exposed to Tazarotene Foam Patch without irradiation Receives: Drug: Tazarotene Foam without irradiation |
| Tazarotene Foam with UVA and UVB irradiation | Experimental | Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation Receives: Drug: Tazarotene Foam with UVA and UVB irradiation |
| Tazarotene Foam with UVA , UVB, and visible light irradiation | Experimental | Subjects will be exposed to Tazarotene Foam with UVA and UVB and visible light irradiation Receives: Drug: Tazarotene Foam with UVA, UVB, and visible light |
| Vehicle Foam without irradiation | Placebo comparator | Subjects will be exposed to Vehicle Foam Patch without irradiation Receives: Drug: Vehicle Foam without irradiation |
| Vehicle Foam with UVA and UVB irradiation | Placebo comparator | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation Receives: Drug: Vehicle Foam with UVA and UVB irradiation |
| Vehicle Foam with UVA and UVB and visible light irradiation | Placebo comparator | Subjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation Receives: Drug: Vehicle Foam with UVA and UVB and visible light irradiation |
| No Treatment without irradiation | Sham comparator | Subjects will be exposed to a Blank Patch without irradiation Receives: Drug: No Treatment without irradiation |
| No Treatment with UVA and UVB irradiation | Sham comparator | Subjects will be exposed to a Blank Patch with UVA and UVB irradiation Receives: Drug: No Treatment with UVA and UVB irradiation |
| No Treatment with UVA and UVB and visible light irradiation | Sham comparator | Subjects will be exposed to a Blank Patch with UVA and UVB and visible light irradiation Receives: Drug: No Treatment with UVA and UVB and visible light irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory skin responses
Evaluation of patch sites for inflammatory skin responses and superficial effects following 24 hours of exposure and following irradiation on Day 2
Measured: Day 2-5 (24, 48, 72 hours following patch application).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study start1 Apr 2010
- Primary completion10 Apr 2010
- Study completion10 Apr 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
- 38 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
- NCT01115322
- Sponsor's protocol ID
- 114573
- Status last verified
- Jun 2017
- First submitted
- 30 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.
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 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 Phototoxic Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01115322
- Acronym / sponsor ID
- 114573
- Conditions
- Acne Vulgaris
- Keywords
- Healthy volunteer study, phototoxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 10 Apr 2010 (actual)
- Study completion
- 10 Apr 2010 (actual)
- First posted
- 4 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 phototoxic 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 phototoxic reaction in healthy adult volunteers. Approximately 40 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.
Each subject will be exposed to three (3) sets of three (3) patches containing Tazarotene Foam, Vehicle Foam and a Blank Patch (no study product). Each patch set will be applied to randomized sites on the subject's back. Patch sets will be removed and evaluated after 24 hours of exposure. The exposed patch sites will then be irradiated (exposed to light) and evaluated at 1 hour post irradiation and at 24, 48, and 72 hours.
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 Foam without irradiationSubjects will be exposed to Tazarotene Foam Patch without irradiation |
| Tazarotene Foam with UVA and UVB irradiation | Experimental | Drug: Tazarotene Foam with UVA and UVB irradiationSubjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation |
| Tazarotene Foam with UVA , UVB, and visible light irradiation | Experimental | Drug: Tazarotene Foam with UVA, UVB, and visible lightSubjects will be exposed to Tazarotene Foam with UVA and UVB and visible light irradiation |
| Vehicle Foam without irradiation | Placebo comparator | Drug: Vehicle Foam without irradiationSubjects will be exposed to Vehicle Foam Patch without irradiation |
| Vehicle Foam with UVA and UVB irradiation | Placebo comparator | Drug: Vehicle Foam with UVA and UVB irradiationSubjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation |
| Vehicle Foam with UVA and UVB and visible light irradiation | Placebo comparator | Drug: Vehicle Foam with UVA and UVB and visible light irradiationSubjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation |
| No Treatment without irradiation | Sham comparator | Drug: No Treatment without irradiationSubjects will be exposed to a Blank Patch without irradiation |
| No Treatment with UVA and UVB irradiation | Sham comparator | Drug: No Treatment with UVA and UVB irradiationSubjects will be exposed to a Blank Patch with UVA and UVB irradiation |
| No Treatment with UVA and UVB and visible light irradiation | Sham comparator | Drug: No Treatment with UVA and UVB and visible light irradiationSubjects will be exposed to a 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 Foam without irradiationEach subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | Tazarotene Foam without irradiation |
| Tazarotene Foam with UVA and UVB irradiationEach subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | Tazarotene Foam with UVA and UVB irradiation |
| Tazarotene Foam with UVA, UVB, and visible lightEach subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | Tazarotene Foam with UVA , UVB, and visible light irradiation |
| Vehicle Foam without irradiationEach subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | Vehicle Foam without irradiation |
| Vehicle Foam with UVA and UVB irradiationEach subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | Vehicle Foam with UVA and UVB irradiation |
| Vehicle Foam with UVA and UVB and visible light irradiationEach subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | Vehicle Foam with UVA and UVB and visible light irradiation |
| No Treatment without irradiationEach subject will be exposed to a blank patch during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | No Treatment without irradiation |
| No Treatment with UVA and UVB irradiationEach subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | No Treatment with UVA and UVB irradiation |
| No Treatment with UVA and UVB and visible light irradiationEach subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal. | Drug | No Treatment with UVA and UVB and visible light irradiation |
Primary outcome
Inflammatory skin responses
Time frame: Day 2-5 (24, 48, 72 hours following patch application).
Evaluation of patch sites for inflammatory skin responses and superficial effects following 24 hours of exposure and following irradiation on Day 2
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.
- 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 114573 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 without irradiation, Tazarotene Foam with UVA and UVB irradiation and Tazarotene Foam with UVA, UVB, and visible light 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 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: Day 2-5 (24, 48, 72 hours following patch application).). 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 NCT01115322, 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 20 Jun 2017.