Objective (Goal)Phase 1/2NCT01650272
Efficacy and Safety Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Androgenetic Alopecia
A Phase 1/2 study testing 5% MInoxidil milky lotion and 5% Minoxidil solution in people with Objective (Goal) and Self-Assessment, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7%… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Objective (Goal), Self-Assessment, Adverse Effects
- What is being tested?
- 5% MInoxidil milky lotion and 5% Minoxidil solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Apr 2013
- Phase
- Phase 1/2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New case male AGA
- Classification Norwood III vertex or IV
Who cannot join
- Have previous AGA treatment in 6 month prior
- Complicated case with other disease condition effect hair such as Anemia, DM, Chronic alcoholism, Autoimmune disease, Thyroid disease, previous GI surgery etc.
- Other scalp lesion such as Psoriasis, Tinea capsitis
- Psychological disorder including trichotillomania
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok, Bangkok, 10700
Kanchalit Thanomkitti, MD, +668 9529 0298, kanchalitt@hotmail.com
Rattapon Thuangtong,, MD
About this study
Official title: An Efficacy and Safety Pilot Study Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Treatment of AGA
5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the alternative solution using butylene glycol as the solvent was invented to solve the problem. In Siriraj hospital the investigators using this new solvent and made our in house product called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.
Read the detailed description
The 5% Minoxidil in solution is the first choice preparation for treatment for Androgenetic Alopecia (AGA), 5% Minoxidil milky lotion is the alternative solution using butylene glycol as the solvent to solve allergic contact dermatitis problem. In Siriraj hospital the investigators using this new solvent and made our in house product called he efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.
- Conditions
- Objective (Goal), Self-Assessment, Adverse Effects
- Being tested
- 5% MInoxidil milky lotion, 5% Minoxidil solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% MInoxidil milky lotionDrug
Also called MInoxidil milky lotion, MInoxidil milk lotion
Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent)
5% Minoxidil solutionDrug
Also called Minoxidil solution, Minoxidil lotion
Patient receive 5% Minoxidil solution (Propylene glycol solvent )
| Study group | Role | What they receive |
|---|---|---|
| 5%Minoxidil solution | Experimental | This arm AGA patient receive 5%Minoxidil solution ( Propylene glycol solvent ) to use for 6 month.
Record efficacy and safety as described. Receives: Drug: 5% Minoxidil solution |
| 5%Minoxidil milky lotion | Experimental | This arm AGA patient receive 5%Minoxidil milky lotion to use for 6 month. Record efficacy and safety as described. Receives: Drug: 5% MInoxidil milky lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution
- Target area hair evaluation
- Hair density (Digital image, DinoLite pro)
- Hair diameter (Electronic outside micrometer)
- Hair count vellus/ non-vellus ratio
- Global photographic review (by 2 Experienced Dermatologist)
- Patient self evaluation ( 7point scale )
Measured: 6 month
Secondary outcomes (1)
Side effect of topical minoxidil
Record side effect such as Erythema, Dryness, Pruritus, Scaling, etc.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective (Goal)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rattapon Thuangtong, Siriraj Hospital
- Investigators
- Rattapon Thuangtong, MD, Principal investigator, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650272
- Sponsor's protocol ID
- SirirajH-006
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Pilot Study Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Treatment of AGA
- ClinicalTrials.gov ID
- NCT01650272
- Acronym / sponsor ID
- SirirajH-006
- Conditions
- Objective (Goal), Self-Assessment, Adverse Effects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 26 Jul 2012 (estimated)
- 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.
5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the alternative solution using butylene glycol as the solvent was invented to solve the problem. In Siriraj hospital the investigators using this new solvent and made our in house product called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.
Detailed description
The 5% Minoxidil in solution is the first choice preparation for treatment for Androgenetic Alopecia (AGA), 5% Minoxidil milky lotion is the alternative solution using butylene glycol as the solvent to solve allergic contact dermatitis problem. In Siriraj hospital the investigators using this new solvent and made our in house product called he efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5%Minoxidil solution | Experimental | Drug: 5% Minoxidil solutionThis arm AGA patient receive 5%Minoxidil solution ( Propylene glycol solvent ) to use for 6 month. Record efficacy and safety as described. |
| 5%Minoxidil milky lotion | Experimental | Drug: 5% MInoxidil milky lotionThis arm AGA patient receive 5%Minoxidil milky lotion to use for 6 month. Record efficacy and safety as described. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New case male AGA
- Classification Norwood III vertex or IV
Key exclusion criteria (4 listed)
- Have previous AGA treatment in 6 month prior
- Complicated case with other disease condition effect hair such as Anemia, DM, Chronic alcoholism, Autoimmune disease, Thyroid disease, previous GI surgery etc.
- Other scalp lesion such as Psoriasis, Tinea capsitis
- Psychological disorder including trichotillomania
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 |
|---|---|---|
| 5% MInoxidil milky lotionAlso: MInoxidil milky lotion, MInoxidil milk lotionPatient receive 5% MInoxidil milky lotion (Butylene glycol solvent) | Drug | 5%Minoxidil milky lotion |
| 5% Minoxidil solutionAlso: Minoxidil solution, Minoxidil lotionPatient receive 5% Minoxidil solution (Propylene glycol solvent ) | Drug | 5%Minoxidil solution |
Primary outcome
Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution
Time frame: 6 month
1. Target area hair evaluation * Hair density (Digital image, DinoLite pro) * Hair diameter (Electronic outside micrometer) * Hair count vellus/ non-vellus ratio 2. Global photographic review (by 2 Experienced Dermatologist) 3. Patient self evaluation ( 7point scale )
1 secondary outcome
Side effect of topical minoxidil
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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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.
Rattapon Thuangtong, MD principal investigator
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 5% MInoxidil milky lotion and 5% Minoxidil solution in people with Objective (Goal) and Self-Assessment, run by Siriraj Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 26 Jul 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rattapon Thuangtong, MD (+662 4194333, rattaponthuangtong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution (time frame: 6 month). 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 26 Jul 2012.