Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001262291
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
26/07/2018
Date last updated
27/02/2023
Date data sharing statement initially provided
1/11/2019
Date results information initially provided
27/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a herbal extract, orally-dosed or topically applied on increasing hair growth and decreasing hair loss in males and females.
Scientific title
Efficacy of Ageratum conyzoides, orally-dosed or topically applied on increasing hair growth and decreasing hair loss in males and females. A randomised double-blind placebo-controlled study.
Secondary ID [1] 294827 0
nil known
Universal Trial Number (UTN)
Trial acronym
AGC-HRG18
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balding 307765 0
Condition category
Condition code
Alternative and Complementary Medicine 306811 306811 0 0
Herbal remedies
Skin 307795 307795 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Product 1: Ageratum conyzoides topical gel 0.5% strength - 2 teaspoon rubbed directly onto the scalp morning and evening.

Product 2: Topical gel placebo - 2 teaspoon rubbed directly onto the scalp morning and evening.

Product 3: Ageratum conyzoides 250 mg capsule taken orally once daily with 250 mL water at breakfast.

Product 4: Placebo capsule - taken orally once daily with 250 mL water at breakfast.

All 4 products are to be used over a 12 week period.

Adherence will be monitored with trial product container return at the end of the study.
Intervention code [1] 301139 0
Treatment: Other
Comparator / control treatment
Topical gel placebo comprised of water and xanthan gum
Placebo capsule comprised of microcrystalline cellulose andmaltodextrin
Control group
Placebo

Outcomes
Primary outcome [1] 305804 0
Change in hair growth (hair density and breakage) - Using the HairCheck instrument (an automated digital tool which measures hair density and breakage)
Timepoint [1] 305804 0
Baseline, weeks, 4, 8 and 12 (primary endpoint) post commencement of intervention
Secondary outcome [1] 346601 0
Hair strength measured using densitometry
Timepoint [1] 346601 0
Baseline, weeks 4, 8 and 12 post commencement of intervention
Secondary outcome [2] 346602 0
hair loss measured using hair comb test
Timepoint [2] 346602 0
Baseline, weeks, 4 8 and 12 post commencement of intervention
Secondary outcome [3] 346603 0
change in hair colour assessed using photographs
Timepoint [3] 346603 0
Baseline, weeks, 4, 8 and 12 post commencement of intervention
Secondary outcome [4] 346607 0
Full blood count measured via blood test
Timepoint [4] 346607 0
Baseline and week 12 post commencement of intervention
Secondary outcome [5] 346608 0
ferritin measured via blood test
Timepoint [5] 346608 0
Baseline and week 12 post commencement of intervention
Secondary outcome [6] 346609 0
Thyroid stimulating hormone measured via blood test
Timepoint [6] 346609 0
Baseline and week 12 post commencement of intervention
Secondary outcome [7] 346610 0
Vitamin D measured via blood test
Timepoint [7] 346610 0
Baseline and week 12 post commencement of intervention
Secondary outcome [8] 346611 0
Testosterone measured via blood test
Timepoint [8] 346611 0
Baseline and week 12 post commencement of intervention
Secondary outcome [9] 346612 0
IGF-1 measured via blood test
Timepoint [9] 346612 0
Baseline and week 12 post commencement of intervention
Secondary outcome [10] 346613 0
HDL measured via blood test
Timepoint [10] 346613 0
Baseline and week 12 post commencement of intervention
Secondary outcome [11] 346614 0
Erdr1 measured via blood test
Timepoint [11] 346614 0
Baseline and week 12 post commencement of intervention
Secondary outcome [12] 346615 0
PTGDS measured via blood test
Timepoint [12] 346615 0
Baseline and week 12 post commencement of intervention
Secondary outcome [13] 346616 0
GPR44 measured via blood test
Timepoint [13] 346616 0
Baseline and week 12 post commencement of intervention
Secondary outcome [14] 346617 0
Subjective improvement measured via questionnaires designed for this study
Timepoint [14] 346617 0
Baseline, weeks 4, 8 and 12 post commencement of intervention
Secondary outcome [15] 349616 0
hair strength measured using Norwood/Hamilton and Ludwig/Salvin scale
Timepoint [15] 349616 0
Baseline, weeks 4, 8 and 12 post commencement of intervention
Secondary outcome [16] 349618 0
hair strength measured using scalp photographs
Timepoint [16] 349618 0

Baseline, weeks 4, 8 and 12 post commencement of intervention
Secondary outcome [17] 349619 0
hair loss measured using scalp photographs
Timepoint [17] 349619 0

Baseline, weeks, 4, 8 and 12 post commencement of intervention
Secondary outcome [18] 349620 0
hair loss measured using tug/pull test
Timepoint [18] 349620 0
Baseline, weeks, 4 8 and 12 post commencement of intervention
Secondary outcome [19] 349902 0
Hair thickness measured using densitometry - Density and thickness are different measures - this is meant to be thickness.
Timepoint [19] 349902 0
Baseline, weeks 4, 8 and 12 post commencement of intervention
Secondary outcome [20] 349903 0
hair thickness measured using Norwood/Hamilton and Ludwig/Salvin scale
Timepoint [20] 349903 0
Baseline, weeks 4, 8 and 12 post commencement of intervention
Secondary outcome [21] 349905 0
hair thickness measured using scalp photographs
Timepoint [21] 349905 0

Baseline, weeks 4, 8 and 12 post commencement of intervention
Secondary outcome [22] 397204 0
PGDT measured via blood tests
Timepoint [22] 397204 0
Baseline and Week 12 post commencement of intervention

Eligibility
Key inclusion criteria
Males and females over 18 years of age reporting hair loss
Participants who agree to maintain a consistent dietary habit throughout the study
Participants who agree to maintain consistent shampoo frequency
Participants who agree to not use other treatment for baldness during the study
Participants agreement to participation in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled
- Scalp conditions or any other genetic disease or issue that could contribute to baldness
- Current use of hair growth formulations and/or use in the past 3 months
- Participants who have taken Radiotherapy to scalp for cancer treatment
- Participants with a current or past history of Cicatricial alopecia
- Women with clinical diagnosis of: Menstrual and/or endocrine disorders, PCOS, Hyper-androgenism.
- Previously used or continue to use ani-hypertensives, steroids, spironolactone, ketokonazole, cytotoxic compounds, anticonvulsant drugs, testosterone or testosterone boosting supplements, oestrogens or progesterone within the last six months
- Reported participation in another hair growth trial 3 months before the start of the study
- Alterations in hair style
- Extreme hair types (eg dreadlocks, afro) and also anyone who has had considerable colouring, bleaching, straightening or curling
- Females not on a suitable form of birth control
- Pregnant, up to 12 months post-partum or lactating

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 33 participants are required to have a 90% chance of detecting a significant change (at the 5% level), in hair density from baseline in the experimental group of 2 mm/cm3. 40 participants per group will be recruited to allow for withdrawals.

Statistical tests will be used to compare differences between groups for hair growth (density, strength and thickness), loss and colour as well as blood markers and questionnaire results. The change in hair density and hair loss will be measured as a within group mean difference change from baseline over the 12 weeks of treatment as well as a comparison between the groups. Statistical analysis will be conducted based on the normality of the data and mean and variance statistical significance (p<0.05) will be calculated using ANOVA and t-tests or Mann-Whitney test if appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2020
Actual
28/09/2020
Date of last participant enrolment
Anticipated
Actual
17/12/2021
Date of last data collection
Anticipated
Actual
18/03/2022
Sample size
Target
160
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299422 0
Commercial sector/Industry
Name [1] 299422 0
Gencor Pacific
Country [1] 299422 0
Hong Kong
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 298708 0
Commercial sector/Industry
Name [1] 298708 0
Pharmako Biotechnologies Pty Ltd
Address [1] 298708 0
Campbell Ave Cromer
NSW 2099 AUS
Country [1] 298708 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300322 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 300322 0
St Lucia QLD 4072
Ethics committee country [1] 300322 0
Australia
Date submitted for ethics approval [1] 300322 0
31/07/2018
Approval date [1] 300322 0
13/02/2019
Ethics approval number [1] 300322 0

Summary
Brief summary
Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study.

Once enrolled in the trial, participants will be randomly allocated to either one of 2 placebo comparator groups or one of two investigational intervention groups. Prior to treatment, participants will undertake various hair assessments including photographs of scalp (unidentifiable), hair comb/count test, hair tug/pull test, densitometry (haircheck®) and also undertake a blood test.
Participants will be asked to consume or apply the allocated product according to the dose prescribed and attend the clinic every month for a repeat of baseline measures excluding the blood test.
At week 12 participants will be asked to attend the clinic for a final assessment including all measures undertaken at baseline, a final blood test and an exit interview.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83294 0
Dr David Briskey
Address 83294 0
RDC Global Pty Ltd
3B/76 Doggett St
Newstead, QLD, 4006
Country 83294 0
Australia
Phone 83294 0
+61 421 784 077
Fax 83294 0
Email 83294 0
[email protected]
Contact person for public queries
Name 83295 0
Ms Amanda Rao
Address 83295 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 83295 0
Australia
Phone 83295 0
+61 414 488 559
Fax 83295 0
Email 83295 0
[email protected]
Contact person for scientific queries
Name 83296 0
Ms Amanda Rao
Address 83296 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead, QLD, 4006
Country 83296 0
Australia
Phone 83296 0
+61 414 488 559
Fax 83296 0
Email 83296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5527Ethical approval    375059-(Uploaded-23-10-2019-12-59-25)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.