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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03178994
Enrollment
42
Registered
2017-06-07
Start date
2017-08-01
Completion date
2018-12-30
Last updated
2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post - Adolescence Acne

Keywords

Post - adolescence acne, Topical 2% ketoconazole cream

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.

Interventions

DRUG2% ketoconazole cream

2% ketoconazole cream applies twice daily

DRUGHydrophilic Cream

Hydrophilic cream (in-house preparation) applies twice daily

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Total numbers of acne reduction10 weeksthe difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)

Secondary

MeasureTime frameDescription
Proportion of patients who achieve clear or almost clear after treatment10 weeksclear or almost clear scored by Adult Female Acne Scoring Tool

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026