Post - Adolescence AcnePhase 3NCT03178994
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
A Phase 3 study testing 2% ketoconazole cream and Hydrophilic Cream in people with Post - Adolescence Acne, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post - Adolescence Acne
- What is being tested?
- 2% ketoconazole cream and Hydrophilic Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2017to 30 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or lactation
- Other active rashes on faces.
- Allergic to ketoconazole or other ingredients of preparation.
- Signs of hyperandrogenism
- Taking anti-androgenic medications.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
About this study
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.
- Conditions
- Post - Adolescence Acne
- Being tested
- 2% ketoconazole cream, Hydrophilic Cream
- Keywords
- Post - adolescence acne, Topical 2% ketoconazole cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% ketoconazole creamDrug
2% ketoconazole cream applies twice daily
Hydrophilic CreamDrug
Hydrophilic cream (in-house preparation) applies twice daily
| Study group | Role | What they receive |
|---|---|---|
| 2% ketoconazole cream | Experimental | 2% ketoconazole cream apply on face twice daily for 10 weeks. Receives: Drug: 2% ketoconazole cream |
| Placebo | Placebo comparator | Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks. Receives: Drug: Hydrophilic Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total numbers of acne reduction
the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)
Measured: 10 weeks
Secondary outcomes (1)
Proportion of patients who achieve clear or almost clear after treatment
clear or almost clear scored by Adult Female Acne Scoring Tool
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Aug 2017
- Primary completion15 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post - Adolescence AcneStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chanat Kumtornrut, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178994
- Sponsor's protocol ID
- 317/60
- Status last verified
- Jul 2018
- First submitted
- 6 Jun 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
- ClinicalTrials.gov ID
- NCT03178994
- Acronym / sponsor ID
- 317/60
- Conditions
- Post - Adolescence Acne
- Keywords
- Post - adolescence acne, Topical 2% ketoconazole cream
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% ketoconazole cream | Experimental | Drug: 2% ketoconazole cream2% ketoconazole cream apply on face twice daily for 10 weeks. |
| Placebo | Placebo comparator | Drug: Hydrophilic CreamHydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Other active rashes on faces.
- Allergic to ketoconazole or other ingredients of preparation.
- Signs of hyperandrogenism
- Taking anti-androgenic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% ketoconazole cream2% ketoconazole cream applies twice daily | Drug | 2% ketoconazole cream |
| Hydrophilic CreamHydrophilic cream (in-house preparation) applies twice daily | Drug | Placebo |
Primary outcome
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)
1 secondary outcome
Proportion of patients who achieve clear or almost clear after treatment
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanat Kumtornrut, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% ketoconazole cream and Hydrophilic Cream in people with Post - Adolescence Acne, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total numbers of acne reduction (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.