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

NCT ID: NCT03178994

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-12-30

Brief Summary

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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

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Conditions

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Post - Adolescence Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2% ketoconazole cream

2% ketoconazole cream apply on face twice daily for 10 weeks.

Group Type EXPERIMENTAL

2% ketoconazole cream

Intervention Type DRUG

2% ketoconazole cream applies twice daily

Placebo

Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.

Group Type PLACEBO_COMPARATOR

Hydrophilic Cream

Intervention Type DRUG

Hydrophilic cream (in-house preparation) applies twice daily

Interventions

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2% ketoconazole cream

2% ketoconazole cream applies twice daily

Intervention Type DRUG

Hydrophilic Cream

Hydrophilic cream (in-house preparation) applies twice daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chanat Kumtornrut, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Department of Medicine, Faculty of Medicine, Chulalongkorn University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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317/60

Identifier Type: -

Identifier Source: org_study_id

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