Clinical Trial Results:
Investigator-initiated clinical research trial on the effects of 5% Minoxidil topical foam on gene expression, hair growth and scalp microenvironment in men with androgenetic alopecia
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Summary
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EudraCT number |
2013-004130-15 |
Trial protocol |
DE |
Global end of trial date |
29 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Dec 2021
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First version publication date |
15 Dec 2021
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Other versions |
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Summary report(s) |
Final report Synopisis |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CRC-AGA-M-A-11
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Charité-Universtitätsmedizin Berlin, Dept. of Dermatology
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Sponsor organisation address |
Charitéplatz 1, Berlin, Germany, 10117
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Public contact |
Dr. Kathrin Hillmann, Charité-Universitätsmedizin Berlin, Dept. of Dermatology, Clinical Research Center Hair Skin Science, 0049 030450518499, kathrin.hillmann@charite.de
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Scientific contact |
Dr. Kathrin Hillmann, Charité-Universitätsmedizin Berlin, Dept. of Dermatology, Clinical Research Center Hair Skin Science, 0049 030450518499, kathrin.hillmann@charite.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Jun 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Sep 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
-Identifying changes on gene expression level associated with minoxidil treatment with special regard to profiles of genes relevant for AGA treatment and for specific effects of early minoxidil action, respectively (1) minoxidil sulfotransferases, potassium channel regulation (2) inflammation, (3) vasoregulation and (4) sexual hormone production and metabolism;
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Protection of trial subjects |
The dosage of the active ingredients of the test product corresponds to 2 x 50 mg minoxidil per day = 100 mg/day.
If, contrary to expectations, a hypersensitivity or allergic reaction should occur, this would lead to the immediate discontinuation of the study participation of the respective volunteer, followed by medical treatment and close medical follow-up.
Each visit is accompanied by a thorough inspection of the scalp by the investigator to ensure safety for the further course of the study.
The subjects must visit the study centre nine times during the course of the 8-week study to document the condition of alopecia by means of the diagnostic tests. These documents are stored in pseudonymised form and used for scientific purposes, again only in anonymised form.
Allergic or hypersensitivity reactions to the hair dye, tattoo ink or disinfectant may occur occasionally (≥1/1000 to ˂1/100) A spot tattoo on the scalp may cause bleeding, which quickly stops. Inflammation, damage or irritation of nerves is generally rare (≥1/10000 to ˂ 1/1000).
In other studies on the use of minoxidil foam, itching, desquamation (2.8%) and inflammation of the skin (1.7%) occurred in 4.4% of cases.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
01 Apr 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Monocenter trial in Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Charité-Universitätsmedizin Berlin: First patient in 19.05.2014 Last patient out 29.09.2014 | |||||||||
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Pre-assignment
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Screening details |
- | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
12 | |||||||||
Number of subjects completed |
12 | |||||||||
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Period 1
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Period 1 title |
Baseline
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Minoxidil / Vertex | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Minoxidil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous foam
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Routes of administration |
Topical use
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Dosage and administration details |
Minoxidl 5% foam = 50mg/g
Apllication of 1g of foam twice daily on the balding spot in vertex area
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Arm title
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No treatment / Occipital | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 2
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Period 2 title |
Week 5
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Is this the baseline period? |
No | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Minoxidil / Vertex | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Minoxidil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous foam
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Routes of administration |
Topical use
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Dosage and administration details |
Minoxidl 5% foam = 50mg/g
Apllication of 1g of foam twice daily on the balding spot in vertex area
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Arm title
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No treatment / Occipital | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 3
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Period 3 title |
Week 9
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Is this the baseline period? |
No | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Minoxidil / vertex | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Minoxidil
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous foam
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Routes of administration |
Topical use
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Dosage and administration details |
Minoxidl 5% foam = 50mg/g
Apllication of 1g of foam twice daily on the balding spot in vertex area
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Arm title
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No treatment / occipital | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Minoxidil / Vertex
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Reporting group description |
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Reporting group title |
No treatment / Occipital
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Reporting group description |
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Reporting group title |
Minoxidil / Vertex
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Reporting group description |
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Reporting group title |
No treatment / Occipital
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Reporting group description |
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Reporting group title |
Minoxidil / vertex
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Reporting group description |
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Reporting group title |
No treatment / occipital
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Reporting group description |
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End point title |
Phototrichogram: hair density [1] | ||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
baseline, week 5, week 9
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive analysis |
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Attachments |
Phototrichogram hair density vertex |
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End point title |
Sebum level | ||||||||||||||||||||||||||||
End point description |
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End point type |
Other pre-specified
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End point timeframe |
Baseline, Week 5, Week 9
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
pH value | ||||||||||||||||||||||||||||
End point description |
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End point type |
Other pre-specified
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End point timeframe |
baseline, week 5, week 9
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From baseline to Week 9
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
no dictionary | ||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Related AEs
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Reporting group description |
- | ||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
