Bio-equivalence Study With Clinical Endpoints in the Trea... | NCT04321070

Studies
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

NCT04321070

Sponsor

Sun Pharmaceutical Industries, Inc.

Status

Completed

Last Update Posted

Apr 10, 2025Actual

Enrollment

550Actual

Phase

Phase 1

Conditions

Acne Vulgaris

Interventions

Clindamycin Phosphate
Clindamycin Phosphate RLD
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2019Actual

Primary Completion Date

Dec 14, 2019Actual

Completion Date

Mar 6, 2020Actual

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2025

Last Update Posted Date

Apr 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Detailed Description

Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

550Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clindamycin Phosphate	Experimental	Topical, once daily, for 84 days.	Drug: Clindamycin Phosphate
Clindamycin Phosphate RLD	Active Comparator	Topical, once daily, for 84 days	Drug: Clindamycin Phosphate RLD
Vehicle of the test product	Placebo Comparator	Topical, once daily, for 84 days	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clindamycin Phosphate	Drug	A thin film of investigation product will be applied to the affected areas of the face once daily	Clindamycin Phosphate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstration of Bioequivalence	Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts	Week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Natalie Yantovskiy	Taro Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catawba Research LLC		Charlotte	North Carolina	28217	United States

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C007084	clindamycin phosphate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided