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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02206802




Registration number
NCT02206802
Ethics application status
Date submitted
31/07/2014
Date registered
1/08/2014
Date last updated
5/10/2018

Titles & IDs
Public title
Minoxidil Response Testing in Females With Female Pattern Hair Loss
Scientific title
Minoxidil Response Testing in Females With Female Pattern Hair Loss
Secondary ID [1] 0 0
AB-IVD-MINOXIDIL-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia 0 0
Female Pattern Hair Loss 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 change in Target Area Hair Count
Timepoint [1] 0 0
baseline to week 24
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 24
Secondary outcome [1] 0 0
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
Timepoint [1] 0 0
baseline to week 12
Secondary outcome [2] 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 [2] 0 0
baseline to week 24
Secondary outcome [3] 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 [3] 0 0
baseline to week 24
Secondary outcome [4] 0 0
Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
Timepoint [4] 0 0
baseline to week 24

Eligibility
Key inclusion criteria
* Females in overall good health
* Age: 18 or older
* Female pattern hair loss
* 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 24 consecutive weeks
* Willing to use an adequate method of birth control (if applicable)
* Negative urine pregnancy test
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous adverse event from topical minoxidil treatment
* History of hypotension
* Uncontrolled hypertension
* Pregnant, nursing, or planning a pregnancy during the study
* Prior hair transplant
* Uses wigs or hair weaves
* Have used minoxidil (topical or oral) anytime during the past 6 months
* Chronic scalp disorders that require medications
* Uses 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
* Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months

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/NCT02206802