HealthyPhase 1NCT00864500
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
A Phase 1 study testing Clobetasol Propionate 0.05% lotion, single exposure and Clobex TM 0.05% Lotion, single exposure in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Clobetasol Propionate 0.05% lotion, single exposure and Clobex TM 0.05% Lotion, single exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2006
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
- A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
- A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
- Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
- Signed and dated informed consent form which meets all criteria of current FDA regulations.
Who cannot join
- History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
- Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
- Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
- Presence of a medical condition requiring regular treatment with prescription drugs.
- Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
- Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
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- Use of any tobacco products in the 30 days prior to dosing.
- Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
- Pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services
Houston, Texas, 77042-4712
About this study
Official title: Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
Read the detailed description
Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study.
Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
- Vasoconstrictor Response
- Conditions
- Healthy
- Being tested
- Clobetasol Propionate 0.05% lotion, single exposure, Clobex TM 0.05% Lotion, single exposure
- Keywords
- Bio-Equivalence, Vasoconstriction, Clobetasol, Healthy adult females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol Propionate 0.05% lotion, single exposureDrug
Also called Clobetasol
A: Experimental Subjects received Alpharma USPD, Inc formulated products
Clobex TM 0.05% Lotion, single exposureDrug
Also called Clobetasol
B:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Clobetasol Propionate 0.05% lotion, single exposure Receives: Drug: Clobetasol Propionate 0.05% lotion, single exposure |
| B | Active comparator | Clobex TM 0.05% Lotion, single exposure Receives: Drug: Clobex TM 0.05% Lotion, single exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasoconstrictor Response
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startNov 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Soran Hong,, M.D., Principal investigator, Novum Pharmaceutical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864500
- Sponsor's protocol ID
- 10504910
- Status last verified
- Jul 2019
- First submitted
- 17 Mar 2009
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Two Clobetasol Propionate 0.05% Topical Lotions
- ClinicalTrials.gov ID
- NCT00864500
- Acronym / sponsor ID
- 10504910
- Conditions
- Healthy
- Keywords
- Bio-Equivalence, Vasoconstriction, Clobetasol, Healthy adult females
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 18 Mar 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.
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
Detailed description
Study Type: Interventional Study Design: An open label, one period, randomized, vasoconstrictor assay study.
Official Title: Bioequivalence of two Clobetasol Propionate 0.05% Topical Lotions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
- Vasoconstrictor Response
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Clobetasol Propionate 0.05% lotion, single exposureClobetasol Propionate 0.05% lotion, single exposure |
| B | Active comparator | Drug: Clobex TM 0.05% Lotion, single exposureClobex TM 0.05% Lotion, single exposure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
- A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
- A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
- Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
- Signed and dated informed consent form which meets all criteria of current FDA regulations.
Key exclusion criteria (9 listed)
- History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
- Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
- Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
- Presence of a medical condition requiring regular treatment with prescription drugs.
- Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
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 |
|---|---|---|
| Clobetasol Propionate 0.05% lotion, single exposureAlso: ClobetasolA: Experimental Subjects received Alpharma USPD, Inc formulated products | Drug | A |
| Clobex TM 0.05% Lotion, single exposureAlso: ClobetasolB:Active Comparator Subjects received Galderma Laboratories, L.P. formulated products | Drug | B |
Primary outcome
Vasoconstrictor Response
Time frame: 24 hours
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 9 Jul 2019.
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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.
Soran Hong,, M.D. principal investigator
Novum Pharmaceutical Research Services
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 Clobetasol Propionate 0.05% lotion, single exposure and Clobex TM 0.05% Lotion, single exposure in people with Healthy, run by Actavis Inc. 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 5 inclusion and 9 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 9 Jul 2019. 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?
Vasoconstrictor Response (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.