Bioequivalence StudyPhase 1NCT04358770

Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream

A Phase 1 study testing Clocortolone Pivalate in people with Bioequivalence Study, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalence Study
What is being tested?: Clocortolone Pivalate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2018to 11 May 2018
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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;

Who cannot join

Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
History of hypersensitivity to the study products or any topical or systemic corticosteroids;

Trial locations and contacts

1 site in 1 country.

United States1 site

WayCro
Dallas, Texas, 75234

Other trials in United States

About this study

Official title: Single Exposure Bioequivalence Study to Evaluate the Vasoconstriction Activity of Topically Applied Cloderm® (Clocortolone Pivalate) 0.1% Cream and Clocortolone Pivalate 0.1% Cream (Taro Pharmaceuticals) in Healthy Male and Female Volunteers With Normal Skin Under Occlusive Conditions.

To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults

Conditions: Bioequivalence Study
Being tested: Clocortolone Pivalate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clocortolone PivalateDrug
Also called Clocortolone
Cream, 0.1%

Study groups in NCT04358770
Study group	Role	What they receive
Test	Experimental	Clocortolone Pivalate Cream, 0.1% Receives: Drug: Clocortolone Pivalate
Reference	Active comparator	Cloderm® (clocortolone pivalate) Cream, 0.1% Receives: Drug: Clocortolone Pivalate

What is being measured

The primary outcome is the main question the study is designed to answer.

AUEC0-24 (area under the effect curve)
value for the blanching intensity vs. time profile
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 201811 May 2018

First posted24 Apr 2020
Study start2 Mar 2018
Primary completion27 Apr 2018
Study completion11 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bioequivalence StudyStudies 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: Health services research
Allocation: Randomised
Intervention model: Single group
Model description: single-exposure, open-label, vasoconstriction response study
Masking: None (open label)
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04358770
Sponsor's protocol ID: CLPC-1801
Status last verified: Apr 2020
First submitted: 21 Apr 2020
Last updated: 24 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bioequivalence Study trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Exposure Bioequivalence Study to Evaluate the Vasoconstriction Activity of Topically Applied Cloderm® (Clocortolone Pivalate) 0.1% Cream and Clocortolone Pivalate 0.1% Cream (Taro Pharmaceuticals) in Healthy Male and Female Volunteers With Normal Skin Under Occlusive Conditions.
ClinicalTrials.gov ID: NCT04358770
Acronym / sponsor ID: CLPC-1801
Conditions: Bioequivalence Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
Collaborators: WAYCro
Study start: 2 Mar 2018 (actual)
Primary completion: 27 Apr 2018 (actual)
Study completion: 11 May 2018 (actual)
First posted: 24 Apr 2020 (actual)
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 pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: single-exposure, open-label, vasoconstriction response study

Arm	Type	Receives
Test	Experimental	Drug: Clocortolone PivalateClocortolone Pivalate Cream, 0.1%
Reference	Active comparator	Drug: Clocortolone PivalateCloderm® (clocortolone pivalate) Cream, 0.1%

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Normal or clinically insignificant dermatological history the Screening visit and Day 1dosing;

Key exclusion criteria (2 listed)

Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;
History of hypersensitivity to the study products or any topical or systemic corticosteroids;

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
Clocortolone PivalateAlso: ClocortoloneCream, 0.1%	Drug	Reference, Test

Primary outcome

AUEC0-24 (area under the effect curve)
Time frame: 24 hours
value for the blanching intensity vs. time profile

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 24 Apr 2020.
Individual participant dataSharing planned: No

Related trials for Bioequivalence Study

RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
RecruitingPhase 1
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
Healthy
Active, not recruitingPhase 1
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
Healthy, Obesity
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-C719 and C719R in Healthy Adult Volunteers
Hypertension
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Clocortolone Pivalate in people with Bioequivalence Study, run by Sun Pharmaceutical Industries, 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 1 inclusion and 2 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 24 Apr 2020. 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?

AUEC0-24 (area under the effect curve) (time frame: 24 hours). 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 NCT04358770.

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 24 Apr 2020.