A pilot study to understand the influence of different head washing methods for anti-dandruff

ISRCTN	ISRCTN18472520
DOI	https://doi.org/10.1186/ISRCTN18472520
Secondary identifying numbers	HAI-DDF-2517

Submission date: 24/02/2021
Registration date: 03/03/2021
Last edited: 19/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Dandruff is a common scalp condition that can be improved by regular use of shampoos containing anti-fungal actives. The efficacy of anti-dandruff shampoos can be assessed by measuring scalp flaking, one of the important dandruff symptoms.
The aim of the study was to test different head washing techniques for the effect on dandruff reduction.

Who can participate?
Adults aged 18 - 60 years, with dandruff.

What does the study involve?
Participants were divided into 2 groups using an on-site controlled washing method or salon-staff washing method. Both groups employed hair washing at a frequency of three-times a week, and dandruff measurement occured once a week from the baseline assessment.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Dahua Garden Hair Salon (China)

When is the study starting and how long is it expected to run for?
March 2016 to January 2017

Who is funding the study?
Unilever (UK/China)

Who is the main contact?
Yuanpei Li, yuanpeili.research@gmail.com

Contact information

Dr Yuanpei Li
Public

Unilever China Investing Co., Ltd
5/F, 66 Linxin Road, Changning District
Shanghai
200335
China

Phone	+86 21 2212 5249
Email	yuanpeili.research@gmail.com

Study information

Study design	Single-center double-blind interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Participant information sheet	No participant information sheet available
Scientific title	Comparison of whole-head and split-head design for the clinical evaluation of anti-dandruff shampoo efficacy
Study objectives	There is a response difference in anti-dandruff efficacy between the on-site controlling method and the salon-staff wash method
Ethics approval(s)	Approved 03/03/2016, Shanghai Nutrition Society (A18, No 380, Fenglin Rd., Shanghai, 200231, China; +86-33676001; yyxh@shhyy.com), ref: 2016-33-01
Health condition(s) or problem(s) studied	Decrease dandruff and improve scalp health
Intervention	This is a single-center, double-blind, randomized, mix genders study. Subjects will remain in the study for about 7 weeks, including a 2-week run-in phase, 1-week balancing, and a 4-week test phase. There will be 2 cells included in this study: one is to follow the whole-head wash procedure with the on-site controlling method, the other is to follow the half-head wash procedure with the routine salon-staff wash method. All qualifying dandruff subjects will be randomly allocated (by sealed envelope) into either of the two wash regime cells: Cell 1: Whole-head, on-site controlling wash, subjects will be randomly allocated to use either test shampoo by themselves at the study site with specific instructions under supervision. Cell 2: Half-head, salon-staff wash, both two test shampoo will be used on either side of their head randomly by salon staff. During the test phase, there will be 12 product application visits (three per week) and 5 dandruff assessments including baseline, week 1 to week 4 (once per week).
Intervention type	Supplement
Primary outcome measure	Scalp visual assessment by a trained assessor at baseline, and once per week from week 1- week 4.
Secondary outcome measures	Adverse events will be measured and recorded throughout the study (4 weeks)
Overall study start date	03/03/2016
Completion date	19/01/2017

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	125
Total final enrolment	120
Key inclusion criteria	1. External subjects (not employees from Unilever or S.P.R.I.M. or Recruiting agency) 2. Aged between 18 and 60 years (inclusive) 3. Dandruff scalp condition (both sides half head total weighted head score AF equivalent ≥32 with grade C, difference between two sides <12) at screen v1 and rescreen v2 4. Subject’s scalp is free from cuts and abrasions 5. Understand the test procedure and agree to adhere to study requirements 6. Hair wash frequency ≥twice per week
Key exclusion criteria	1. Currently pregnant, trying to be pregnant or breastfeeding (female only) 2. Have a history of serious illness that may require regular systemic medication (e.g. cancer, thyroid dysfunction, liver dysfunction) which may influence the study outcome (at the discretion of the Study Doctor). Subjects with stable thyroid conditions (medication / dosage has not changed within 12 months of the start of the study) may be included at the discretion of the Study Doctor 3. Current or frequent systemic treatment by a doctor for any active skin condition, on any body site 4. Sufferers of eczema of any area of the head or neck (during adult life) 5. Seborrhoeic dermatitis on the head or neck or severe dandruff, currently or within last 6 months 6. Diagnosed with psoriasis and have active lesions within last 2 years 7. Use of systemic anti-inflammatory medication on a frequent basis (at the discretion of the Study Doctor) Use of topical steroids on the scalp currently or within last 6 months 8. Recent or current regular use of systemic or inhaled steroids 9. Regular use of any other medication / topical products which might affect the outcome of the study (at the discretion of the Study Doctor) 10. Hair dyed/permed or chemically treated within 2 weeks of the run-in period 11. Have head lice or ringworm at any point in the study • Have any known allergies or sensitivities to ingredients in study products 12. Hair loss greater than Hamilton grade 3 for male or Ludwig grade 1 for female 13. Use of ketoconazole-based shampoo (e.g. Nizoral, Neutrogena Long-lasting) within last 6 months or Selenium sulfide-based shampoo (e.g. Selsun, L’Oreal Intensive Anti-Dandruff, Head and Shoulders intensive) within the last 3 months 14. Use of anti-dandruff shampoo or other anti-dandruff hair/scalp care products within the last 2 months 15. Concurrent participation in another scalp clinical study 16. Use of any medicine which in the opinion of the Study Doctor may affect the outcome of the study
Date of first enrolment	28/10/2016
Date of final enrolment	30/12/2016

Locations

Countries of recruitment

China

Study participating centre

Dahua Garden Hair Salon

No.151 Jiandong Road
Beilin District
Xi'an City
710000
China

Sponsor information

Unilever (China)
Industry

Unilever China Investing Co., Ltd
5/F, 66 Linxin Road, Changning District
Shanghai
200335
China

Phone	+86 21 2212 5249
Email	ryan.lee@unilever.com
Website	https://www.unilever.com.cn
"ROR"	https://ror.org/01b0cs606

Funders

Funder type

Industry

Unilever
Government organisation / For-profit companies (industry)

Alternative name(s): Unilever Global, Unilever PLC, U
Location: United Kingdom

Results and Publications

Intention to publish date	01/10/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal. We also planned for sharing participant-level data by submitting the data to the journal as supplementary materials.
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		31/05/2021	19/05/2023	Yes	No

Editorial Notes

19/05/2023: Publication reference added.
01/03/2021: Trial’s existence confirmed by Unilever.