Back to resultsThe Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Primary Purpose
Post - Adolescence Acne
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
2% ketoconazole cream
Hydrophilic Cream
Sponsored by
About this trial
This is an interventional treatment trial for Post - Adolescence Acne focused on measuring Post - adolescence acne, Topical 2% ketoconazole cream
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.
Sites / Locations
- Department of Medicine, Faculty of Medicine, Chulalongkorn University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
2% ketoconazole cream
Placebo
Arm Description
2% ketoconazole cream apply on face twice daily for 10 weeks.
Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.
Outcomes
Primary Outcome Measures
Total numbers of acne reduction
the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)
Secondary Outcome Measures
Proportion of patients who achieve clear or almost clear after treatment
clear or almost clear scored by Adult Female Acne Scoring Tool
Full Information
NCT ID
NCT03178994
First Posted
June 6, 2017
Last Updated
February 6, 2019
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT03178994
Brief Title
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Official Title
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post - Adolescence Acne
Keywords
Post - adolescence acne, Topical 2% ketoconazole cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2% ketoconazole cream
Arm Type
Experimental
Arm Description
2% ketoconazole cream apply on face twice daily for 10 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.
Intervention Type
Drug
Intervention Name(s)
2% ketoconazole cream
Intervention Description
2% ketoconazole cream applies twice daily
Intervention Type
Drug
Intervention Name(s)
Hydrophilic Cream
Intervention Description
Hydrophilic cream (in-house preparation) applies twice daily
Primary Outcome Measure Information:
Title
Total numbers of acne reduction
Description
the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients who achieve clear or almost clear after treatment
Description
clear or almost clear scored by Adult Female Acne Scoring Tool
Time Frame
10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanat Kumtornrut, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Faculty of Medicine, Chulalongkorn University
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
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