Acne VulgarisPhase 1NCT01114841
A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers
A Phase 1 study testing Tazarotene Foam in people with Acne Vulgaris, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 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), III (burns moderately; tans gradually), or IV (rarely burns; tans with ease) 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:
Show all 12Show fewer
- 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 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.
Show all 20Show fewer
- 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 Contact Sensitization Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 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 0.1% to induce contact sensitization following repeated exposure under maximal stress conditions in healthy adult volunteers. Approximately 240 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.
All subjects will be exposed to patches containing tazarotene foam and vehicle foam. Inflammatory skin responses (eg, erythema, edema, papules) or superficial effects at patch sites will be visually assessed and scored according to the corresponding grading scales.
The study duration will be 6 weeks or 9 weeks and will consist of the following phases: 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 Foam, Vehicle Foam
- 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
Patches containing Tazarotene Foam 0.1% will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours.
There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge).
These patches will then be evaluated at 24, 48, and 72 hours.
There may be a second rest period and a second 48-hour patch application and evaluation, if required.
Vehicle FoamDrug
Patches containing Vehicle Foam will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours.
There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge).
These patches will then be evaluated at 24, 48, and 72 hours.
There may be a second rest period and a second 48-hour patch application and evaluation, if required.
| 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 |
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: Induction: Baseline-Week 3 - every 48 to 72 hours; Challenge: Week 6 - after 48 hours, then again at 24, 48, and 72 hours; if indicated a second challenge: Week 9 after 48 hours, then at 24, 48, and 72 hours following patch removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study start31 Mar 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
- 254 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
- NCT01114841
- Sponsor's protocol ID
- 114572
- Status last verified
- Jun 2017
- First submitted
- 29 Apr 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
Berg JE, Bowman JP, Saenz AB. Cumulative irritation potential and contact sensitization potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Cutis. 2012 Oct;90(4):206-11.
PubMed 23259209
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 Contact Sensitization Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01114841
- Acronym / sponsor ID
- 114572
- Conditions
- Acne Vulgaris
- Keywords
- Healthy Volunteer Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 31 Mar 2010 (actual)
- Primary completion
- 26 Jun 2010 (actual)
- Study completion
- 26 Jun 2010 (actual)
- First posted
- 3 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.
This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 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 0.1% to induce contact sensitization following repeated exposure under maximal stress conditions in healthy adult volunteers. Approximately 240 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.
All subjects will be exposed to patches containing tazarotene foam and vehicle foam. Inflammatory skin responses (eg, erythema, edema, papules) or superficial effects at patch sites will be visually assessed and scored according to the corresponding grading scales.
The study duration will be 6 weeks or 9 weeks and will consist of the following phases: 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
- 2
| 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 |
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), III (burns moderately; tans gradually), or IV (rarely burns; tans with ease) 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 (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 FoamPatches containing Tazarotene Foam 0.1% will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required. | Drug | Tazarotene Foam |
| Vehicle FoamPatches containing Vehicle Foam will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required. | Drug | Vehicle Foam |
Primary outcome
Inflammatory skin responses
Time frame: Induction: Baseline-Week 3 - every 48 to 72 hours; Challenge: Week 6 - after 48 hours, then again at 24, 48, and 72 hours; if indicated a second challenge: Week 9 after 48 hours, then at 24, 48, and 72 hours following patch removal)
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 14 Jun 2017.
- Background: PubMed 23259209Berg JE, Bowman JP, Saenz AB. Cumulative irritation potential and contact sensitization potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Cutis. 2012 Oct;90(4):206-11.
- Results for study 114572 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.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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 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 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 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: Induction: Baseline-Week 3 - every 48 to 72 hours; Challenge: Week 6 - after 48 hours, then again at 24, 48, and 72 hours; if indicated a second challenge: Week 9 after 48 hours, then at 24, 48, and 72 hours following patch removal)). 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 NCT01114841, 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.