The ability of anti-dandruff shampoo to reduce dandruff, itching, scalp histamine, and scalp microbiome in subjects with moderate to severe dandruff
| ISRCTN | ISRCTN79977393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79977393 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Faculty of Medicine, Universitas Kristen Duta Wacana |
| Funder | Rohto Mentholatum (Vietnam) Co., Ltd |
- Submission date
- 17/11/2024
- Registration date
- 27/11/2024
- Last edited
- 26/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Dandruff is a common chronic scalp condition that affects more than half of the world's population and has been known since antiquity. Despite its high prevalence, the exact pathophysiology is not well established and is understood to be multifactorial, with factors such as fungal colonization, sebaceous gland activity, and individual factors being implicated. There is a need for an effective and safe shampoo that can target the above factors. The aim of this study is comparing the effects of an anti-dandruff shampoo containing selenium sulfide with a shampoo containing selenium sulfide and piroctone olamine on dandruff, itching, histamine levels or inflammatory markers, and the scalp microbiome in subjects with moderate to severe dandruff.
Who can participate?
The participants of this study are healthy males and females aged 18-65 years old who had not undergone menopause (female) with moderate to severe dandruff.
What does the study involve?
Participants would be instructed to use the randomly assigned shampoo three times a week. Scalp dandruff and itching will be measured at baseline, day 14, and 28. Scalp histamine levels or inflammation markers and scalp microbiome will be measured at baseline and day 28.
What are the possible benefits and risks of participating?
The possible benefits are shampoo and laboratory tests to determine the severity of dandruff, histamine levels or inflammatory markers, and the condition of the microbiome on the scalp, while the risks are a feeling of burning, stinging or pain, accompanied by changes to the scalp in the form of redness, pimples, lumps and/ or discharge.
Where is the study run from?
Faculty of Medicine, Universitas Kristen Duta Wacana (Indonesia).
When is the study starting and how long is it expected to run for?
July 2024 to February 2025
Who is funding the study?
Rohto Mentholatum (Vietnam) Co., Ltd.
Who is the main contact?
Arum Krismi, penelitian.arumkrismi@gmail.com
Contact information
Public, Scientific, Principal investigator
Sekar Bakung Residence no. E1
Jl. Imogiri Barat, Semail, Kel. Bangunharjo, Kec. Sewon, Daerah Istimewa Yogyakarta
Bantul
55188
Indonesia
 ORCID ID |
0000-0003-4276-3025 |
|---|---|
| Phone | +62 811254861 |
| dr_arumkrismi@staff.ukdw.ac.id |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre interventional double-blinded randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 46416 PIS 27.09.2024.pdf |
| Scientific title | The effect of anti-dandruff shampoo on scalp dandruff, itch, histamine, and microbiome |
| Study objectives | Anti-dandruff shampoo could reduce dandruff, itch, histamine levels, and improve scalp microbiome |
| Ethics approval(s) |
Approved 15/10/2024, Health Research Ethics Committee of Faculty of Medicine, Universitas Kristen Duta Wacana (GEDUNG KOINONIA Jl. Dr. Wahidin Sudirohusodo 5-25 Kotabaru, Gondokusuman, Yogyakarta, 55224, Indonesia; +62 89511803304; kepk@staff.ukdw.ac.id), ref: 1663/C.16/FK/2O24 |
| Health condition(s) or problem(s) studied | Moderate to severe dandruff |
| Intervention | Interventions: anti-dandruff shampoo containing selenium sulfide, selenium sulfide and piroctone olamine, and placebo Randomization: simple randomization Details of interventions: Shampooing 3 times a week with one of the products, about 10 mL shampoo on every shampooing, for 4 weeks |
| Intervention type | Other |
| Primary outcome measure(s) |
Scalp dandruff measured using Adherent Scalp Flaking Score (ASFS) at baseline, day 14, and 28 |
| Key secondary outcome measure(s) |
1. Itch intensity measured using Worst Itching Intensity-Numerical Rating Scale (WI-NRS) at baseline, day 14, and 28 |
| Completion date | 28/02/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 99 |
| Key inclusion criteria | 1. Had not undergone menopause for female 2. Have Adherent Scalp Flaking Score (ASFS) of ≥ 24 at the baseline visit 3. Comply with the procedure, agree to complete the study, and provide written informed consent |
| Key exclusion criteria | 1. Having scalp diseases or scalp scarring 2. Having history of contact dermatitis at the scalp 3. Having difficulties in verbal and written communication 4. Having difficulties in mobility 5. Using medication of oral anti-fungal, immunosuppressant agents, anti-inflammatory, or chronic antihistamine drugs within 4 weeks prior to baseline 6. Using medication of anti-dandruff, anti-psoriatic, or anti-seborrhoeic dermatitis shampoos within 2 weeks prior to baseline; and any other significant medical condition |
| Date of first enrolment | 07/12/2024 |
| Date of final enrolment | 11/01/2025 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Jl. Dr. Wahidin Sudirohusodo no. 5-25, Kotabaru, Kel. Gondokusuman
Yogyakarta
55224
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and/ or analysed during the current study are/ will be available upon request from Arum Krismi (dr_arumkrismi@staff.ukdw.ac.id). The type of data will be shared as requested in the format of excel, when all of the results are already published for about 5 years since the end of the study, to view only, with other investigators of the same field of study (dandruff), without consent from participants because the data would not contain participants' identity except their age and sex. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/09/2024 | 26/11/2024 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 46416 PIS 27.09.2024.pdf
- Participant information sheet
Editorial Notes
26/11/2024: Trial's existence confirmed by Health Research Ethics Committee of Faculty of Medicine, Universitas Kristen Duta Wacana.
