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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02198261




Registration number
NCT02198261
Ethics application status
Date submitted
21/07/2014
Date registered
23/07/2014
Date last updated
5/10/2018

Titles & IDs
Public title
Minoxidil Response Testing in Males With Androgenetic Alopecia
Scientific title
Minoxidil Response Testing in Males With Androgenetic Alopecia
Secondary ID [1] 0 0
AB-IVD-MINOXIDIL-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - 5% minoxidil topical foam

Predicted as non-responders - Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.

Predicted as responders - Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.


Treatment: Drugs: 5% minoxidil topical foam
5% minoxidil topical foam
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair count in the target region
Timepoint [1] 0 0
baseline to week 16
Primary outcome [2] 0 0
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
Timepoint [2] 0 0
baseline to week 16
Secondary outcome [1] 0 0
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth
Timepoint [1] 0 0
baseline to week 16
Secondary outcome [2] 0 0
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region
Timepoint [2] 0 0
baseline to week 16
Secondary outcome [3] 0 0
Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
Timepoint [3] 0 0
baseline to week 16

Eligibility
Key inclusion criteria
* Males in overall good health
* Age: 18 to 49
* Diagnosed with male androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
* Willing to have a mini dot tattoo placed in the target area of the scalp
* Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
* Able to give informed consent
* Able to comply with the study requirements for 16 consecutive weeks
Minimum age
18 Years
Maximum age
49 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous adverse event from topical minoxidil treatment
* Does not use and have not used in the past 6 months anti-androgen therapy such as finasteride
* Does not use and have not used in the past 6 months minoxidil (topical or oral)
* Does not take medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
* Folliculitis
* Scalp psoriasis
* Seborrheic dermatitis
* Inflammatory scalp conditions such as lichen planopilaris

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2018
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
India
State/province [3] 0 0
Mumbai
Country [4] 0 0
Italy
State/province [4] 0 0
Florence

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Applied Biology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Keene, MD
Address 0 0
Physicians Hair Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02198261