The Study of Efficacy and Safety of 2% Ketoconazole Cream... | NCT03178994

Studies
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne

NCT03178994

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Feb 8, 2019Actual

Enrollment

42Actual

Phase

Phase 3

Conditions

Post - Adolescence Acne

Interventions

2% ketoconazole cream
Hydrophilic Cream

Countries

Thailand

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

Jul 2018

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

Aug 1, 2017Actual

Primary Completion Date

Sep 15, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Jun 6, 2017

First Submission Date that Met QC Criteria

Jun 6, 2017

First Posted Date

Jun 7, 2017Actual

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

Feb 6, 2019

Last Update Posted Date

Feb 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

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

To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12 weeks.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2% ketoconazole cream	Experimental	2% ketoconazole cream apply on face twice daily for 10 weeks.	Drug: 2% ketoconazole cream
Placebo	Placebo Comparator	Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.	Drug: Hydrophilic Cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2% ketoconazole cream	Drug	2% ketoconazole cream applies twice daily	2% ketoconazole cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total numbers of acne reduction	the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)	10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients who achieve clear or almost clear after treatment	clear or almost clear scored by Adult Female Acne Scoring Tool	10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

regular menstrual cycle with mild degree of post - adolescence acne
agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively.

Exclusion Criteria:

Pregnancy or lactation
Other active rashes on faces.
Allergic to ketoconazole or other ingredients of preparation.
Signs of hyperandrogenism
Taking anti-androgenic medications.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chanat Kumtornrut, MD	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Faculty of Medicine, Chulalongkorn University		Bangkok		10330	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided