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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03178994
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : February 8, 2019
Information provided by (Responsible Party):
Chulalongkorn University

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.

Condition or disease Intervention/treatment Phase
Post - Adolescence Acne Drug: 2% ketoconazole cream Drug: Hydrophilic Cream Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: 2% ketoconazole cream
2% ketoconazole cream apply on face twice daily for 10 weeks.
Drug: 2% ketoconazole cream
2% ketoconazole cream applies twice daily

Placebo Comparator: Placebo
Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.
Drug: Hydrophilic Cream
Hydrophilic cream (in-house preparation) applies twice daily

Primary Outcome Measures :
  1. Total numbers of acne reduction [ Time Frame: 10 weeks ]
    the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)

Secondary Outcome Measures :
  1. Proportion of patients who achieve clear or almost clear after treatment [ Time Frame: 10 weeks ]
    clear or almost clear scored by Adult Female Acne Scoring Tool

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03178994

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Department of Medicine, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
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Principal Investigator: Chanat Kumtornrut, MD Chulalongkorn University
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Responsible Party: Chulalongkorn University Identifier: NCT03178994    
Other Study ID Numbers: 317/60
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chulalongkorn University:
Post - adolescence acne
Topical 2% ketoconazole cream
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors