The effectiveness and safety evaluation of hair growth promotor containing teak leaf extract
| ISRCTN | ISRCTN24541842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24541842 |
- Submission date
- 04/12/2023
- Registration date
- 08/01/2024
- Last edited
- 30/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and aims
Teak leaf extract exhibits 5-alpha reductase inhibitory activity and other biological activities related to hair growth applications. Therefore, teak leaf extract is a good source of natural ingredients for developing hair growth promotors. This study aims to evaluate the effectiveness and safety of hair tonic containing teak leaf extract
Who can participate?
Men who suffer from androgenic alopecia (type II-V), aged 20-60 years old
What does the study involve?
This is a study to evaluate of effectiveness and safety of a hair tonic containing teak leaf extract compared with 5% minoxidil (positive control) and a placebo.
What are the possible benefits and risks of participating?
The participants who enroll in this study might benefit from the treatment of hair growth with less of side effects. However, the participants might have skin irritation to the received product which can be treated by a dermatologist until complete recovery.
Where is the study run from?
The Cosmetics and Natural Products Research Center, Naresuan University (Thailand)
When is the study starting and how long is it expected to run for?
July 2021 to February 2022
Who is funding the study?
The National Research Council of Thailand (NRCT) (Grant number N21A640421) (Thailand)
Who is the main contact?
Associate Professor Neti Waranuch, Ph.D., netiw@nu.ac.th
Professor Kornkanok Ingkaninan, Ph.D., k_ingkaninan@yahoo.com
Miss Nutchaninad Tanuphol, nutchaninadt62@nu.ac.th
Contact information
Public, Scientific, Principal Investigator
Faculty of Pharmaceutical Sciences
Naresuan University
99 Moo.9
Tha Pho Subdistrict
Mueang District
Phitsanulok
65000
Thailand
 ORCID ID |
0000-0003-3350-9017 |
|---|---|
| Phone | +66 909855982 |
| nutchaninadt62@nu.ac.th |
Scientific
Department of Pharmaceutical Chemistry and Pharmacognosy, Faculty of Pharmaceutical Sciences, Naresuan University
Phitsanulok
65000
Thailand
| ORCID ID |
0000-0002-4415-8489 |
|---|---|
| Phone | +66 81-4817305 |
| k_ingkaninan@yahoo.com |
Scientific
Department of Pharmaceutical Chemistry and Pharmacognosy, Faculty of Pharmaceutical Sciences, Naresuan University
Phitsanulok
65000
Thailand
| ORCID ID |
0000-0003-3350-9017 |
|---|---|
| Phone | +66 90-9855982 |
| nutchaninadt62@nu.ac.th |
Study information
| Study design | Double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | The effectiveness and safety evaluation of hair growth promotor containing Tectona grandis L. (Teak) leaves extract |
| Study objectives | Hair tonic containing teak leaf extract could promote hair growth effects |
| Ethics approval(s) |
Approved 20/07/2021, Naresuan University Institutional Review Board (NU-IRB) (4th Floor Mahathammaracha Building, Division of Research Promotion, Naresuan University, Phitsanulok, 65000, Thailand; +6655968752; nu-irb-board1@nu.ac.th), ref: P10123/64 |
| Health condition(s) or problem(s) studied | Hair growth promotor in men who suffer from androgenic alopecia |
| Intervention | The participants were randomized into 3 groups: 1. Patients receiving a 5% minoxidil (positive control), 2. Patients receiving a hair tonic containing teak leaf extract (the tested product) 3. Patients receiving a base of hair tonic without teak leaf extract (placebo) The participants were identified by a Unicode which was blinded to investigators. All products were uniformly packaged and labeled with codes by a researcher not involved in the investigation. The participants were assigned to apply 3-5 drops (0.5 mL) of the received product twice a day (morning and night) and to use the provided shampoo for washing their hair at least once a day. Participants were not permitted to use other hair growth promoters. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Target area hair count (TAHC), hair density, anagen hair count, and telogen hair count were measured by macro-photography trichoscopy Leviacam at baseline and every 4 weeks for a total duration of 24 weeks 2. Hair shedding measured using a combing test macro-photography trichoscopy Levicam at baseline and every 4 weeks for a total duration of 24 weeks 3. Safety and adverse effects measured by a dermatologist evaluation at baseline and every 4 weeks for a total duration of 24 weeks 4. Hair growth satisfaction measured using a questionnaire at the end of the study (week 24) |
| Secondary outcome measures | There were no secondary outcome measures |
| Overall study start date | 10/01/2021 |
| Completion date | 20/07/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 60 Years |
| Sex | Male |
| Target number of participants | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | Men who suffered from androgenic alopecia defined by Hamilton-Norwood type II to V, age 20-60 years old. |
| Key exclusion criteria | 1. A lesion on the scalp 2. Sensitivity to hair growth promotors or minoxidil 3. Use of other hair-regrowth products for 3 months and/or minoxidil for 6 months before enrolling in this project 4. Systemic steroids for more than 14 days within 2 months before baseline evaluation 5. Medical history of radiation on the scalp 6. Personal chronic decreases i.e. chronic kidney disease, and non-controlled blood pressure |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 20/02/2022 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Phitsanilok
65000
Thailand
Sponsor information
Government
196 Phaholothin Rd. Chatujak District
Bangkok
10900
Thailand
| Phone | +6625791370 |
|---|---|
| saraban@nrct.go.th | |
| Website | https://www.nrct.go.th/en |
"ROR" |
https://ror.org/018wfhg78 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NRCT
- Location
- Thailand
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the study were stored in a non-publicly available repository at the Faculty of Pharmaceutical Sciences, Narasuan University, Thailand. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 02/01/2024 | No | No | ||
| Results article | 30/10/2024 | 30/10/2024 | Yes | No |
Additional files
Editorial Notes
30/10/2024: Publication reference added.
02/01/2024: Trial's existence confirmed by Naresuan University Institutional Review Board (NU-IRB).
