Acne VulgarisPhase 1NCT01019603
A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris
A Phase 1 study testing Tazarotene and Tazaroc Gel 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 assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are based on previous clinical studies with Tazorac Gel and Tazorac Cream. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Tazarotene and Tazaroc Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2009to 20 Dec 2009
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female 12 years of age or older who is in good general health.
- Have an Investigator's Static Global Assessment (ISGA) score of 3 or greater at baseline. The area considered for the ISGA must be confined to the face.
- Regular menstrual cycle prior to study entry (as reported by the subject) for females of childbearing potential.
- Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.
- Women who are not currently sexually active must agree to use medically accepted methods of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.
- Nonsmoker or smoker with at least 30 days abstinence from smoking or using nicotine-containing products prior to study entry and willing not to smoke or to use nicotine-containing products throughout the study.
- Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed
Who cannot join
- Female who is pregnant, trying to become pregnant, or breast feeding.
- History of known or suspected intolerance to any of the ingredients of the study products.
- Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
- Use of systemic corticosteroids within the past 4 weeks.
- Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
- Concurrent use of medications known to be photosensitizers because of the possibility of augmented photosensitivity.
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- Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids) within the past 2 weeks.
- Concomitant use of of facial products such as: abradants, facials, peels containing glycolic or other acids .
- Facial procedure (eg, chemical or laser peel or microdermabrasion) performed by an esthetician, beautician, physician, nurse, or other practitioner within the past 2 weeks.
- History or evidence of skin conditions other than acne (eg, eczema) that would interfere with the subject's participation in the study.
- Consumption of alcohol within 24 hours prior to study product application on days 8, 12, 15, 18, 20, and 22 and within 72 hours post application on day 22.
- Consumption of xanthine-containing beverages or products (eg, caffeinated coffee, tea, over-the counter medication for cold symptoms) within 24 hours prior to study product application on days 8, 12, 15, 18, 20, and 22 and within 72 hours post-application on day 22.
- Anticipated need to engage in activities or exercise that would cause profuse sweating during the study.
- Anticipated need for surgery or hospitalization during the study.
- Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight or tanning beds) during the study.
- Concurrent involvement in another investigational study or participation within 30 days prior to the start of this study.
- Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
- Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a contract research organization involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris
The purpose of this study is to assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are based on previous clinical studies with Tazorac Gel and Tazorac Cream.
Read the detailed description
A single-center, randomized, open-label, phase 1, comparative bioavailability study in subjects with moderate to severe acne vulgaris. Approximately 30 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: Tazorac Gel). Study product will be applied once daily for 22 days to the face, upper chest, upper back, and shoulders. Following the baseline visit, subjects will return to the study center daily for study product application. Blood samples to determine plasma concentrations of tazarotenic acid will be collected before study product application on days 1, 8, 12, 15, 18, 20, and 22, and collected at multiple time points over a 72 hour period on days 22 through 25.
- Conditions
- Acne Vulgaris
- Being tested
- Tazarotene, Tazaroc Gel
- Keywords
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazaroteneDrug
Also called Tazorac
Topical Tazarotene foam applied daily for 22 days.
Tazaroc GelDrug
Also called Tazorac
Topical tazarotene gel applied daily for 22 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tazarotene foam 0.1% Receives: Drug: Tazarotene |
| 2 | Active comparator | Tazaroc Gel 0.1% Receives: Drug: Tazaroc Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of tazarotenic acid in subjects with acne vulgaris
Measured: Days 1, 8, 12, 15, 18, 20, 22 (pre-dose and 3, 4.5, 6, 7.5, 9, 12, 16, 20, 24, 38, 48, 62, and 72 hr post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study start12 Oct 2009
- Primary completion20 Dec 2009
- Study completion20 Dec 2009
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
- None (open label)
- Enrolment
- 30 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
- NCT01019603
- Sponsor's protocol ID
- 114565
- Status last verified
- Jun 2017
- First submitted
- 19 Nov 2009
- Last updated
- 23 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
Jarratt M, Werner CP, Alio Saenz AB. Tazarotene foam versus tazarotene gel: a randomized relative bioavailability study in acne vulgaris. Clin Drug Investig. 2013 Apr;33(4):283-9. doi: 10.1007/s40261-013-0065-1.
PubMed 23456673
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01019603
- Acronym / sponsor ID
- 114565
- Conditions
- Acne Vulgaris
- Keywords
- Acne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 12 Oct 2009 (actual)
- Primary completion
- 20 Dec 2009 (actual)
- Study completion
- 20 Dec 2009 (actual)
- First posted
- 25 Nov 2009 (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 assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are based on previous clinical studies with Tazorac Gel and Tazorac Cream.
Detailed description
A single-center, randomized, open-label, phase 1, comparative bioavailability study in subjects with moderate to severe acne vulgaris. Approximately 30 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: Tazorac Gel). Study product will be applied once daily for 22 days to the face, upper chest, upper back, and shoulders. Following the baseline visit, subjects will return to the study center daily for study product application. Blood samples to determine plasma concentrations of tazarotenic acid will be collected before study product application on days 1, 8, 12, 15, 18, 20, and 22, and collected at multiple time points over a 72 hour period on days 22 through 25.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TazaroteneTazarotene foam 0.1% |
| 2 | Active comparator | Drug: Tazaroc GelTazaroc Gel 0.1% |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 12 years of age or older who is in good general health.
- Have an Investigator's Static Global Assessment (ISGA) score of 3 or greater at baseline. The area considered for the ISGA must be confined to the face.
- Regular menstrual cycle prior to study entry (as reported by the subject) for females of childbearing potential.
- Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.
- Women who are not currently sexually active must agree to use medically accepted methods of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.
Key exclusion criteria (18 listed)
- Female who is pregnant, trying to become pregnant, or breast feeding.
- History of known or suspected intolerance to any of the ingredients of the study products.
- Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
- Use of systemic corticosteroids within the past 4 weeks.
- Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
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 |
|---|---|---|
| TazaroteneAlso: TazoracTopical Tazarotene foam applied daily for 22 days. | Drug | 1 |
| Tazaroc GelAlso: TazoracTopical tazarotene gel applied daily for 22 days. | Drug | 2 |
Primary outcome
Plasma concentrations of tazarotenic acid in subjects with acne vulgaris
Time frame: Days 1, 8, 12, 15, 18, 20, 22 (pre-dose and 3, 4.5, 6, 7.5, 9, 12, 16, 20, 24, 38, 48, 62, and 72 hr post-dose
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 23 Jun 2017.
- Background: PubMed 23456673Jarratt M, Werner CP, Alio Saenz AB. Tazarotene foam versus tazarotene gel: a randomized relative bioavailability study in acne vulgaris. Clin Drug Investig. 2013 Apr;33(4):283-9. doi: 10.1007/s40261-013-0065-1.
- 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.
- Results for study 114565 can be found on the GSK Clinical Study Register.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 and Tazaroc Gel 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 8 inclusion and 18 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 23 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. 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?
Plasma concentrations of tazarotenic acid in subjects with acne vulgaris (time frame: Days 1, 8, 12, 15, 18, 20, 22 (pre-dose and 3, 4.5, 6, 7.5, 9, 12, 16, 20, 24, 38, 48, 62, and 72 hr post-dose). 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 NCT01019603, 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 23 Jun 2017.