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OpenTrials
Completed

NCT Number: NCT03178994

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

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.

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Key information

Conditions

Post - Adolescence Acne

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of Medicine, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2% ketoconazole cream

Drug

2% ketoconazole cream applies twice daily

Hydrophilic Cream

Drug

Hydrophilic cream (in-house preparation) applies twice daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2017
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.