Evaluation of a dermocosmetic regimen for acne-prone skin in volunteers with mild, moderate or severe skin conditions

ISRCTN	ISRCTN12623932
DOI	https://doi.org/10.1186/ISRCTN12623932
Integrated Research Application System (IRAS)	348570
Sponsor	Beiersdorf (Germany)
Funder	Beiersdorf

Submission date: 05/08/2026
Registration date: 06/08/2026
Last edited: 06/08/2026

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Acne is a common skin condition that can affect a person's appearance, confidence and quality of life. Many skincare products are available for acne-prone skin, but more evidence is needed to understand how well they work in real-world settings.

This study aims to evaluate the effectiveness and tolerability of a dermocosmetic skincare regimen consisting of Eucerin DermoPure products and Eucerin Oil Control Sun Protection SPF50+ in people with mild to severe acne-prone skin.

Who can participate?
People aged 12 to 50 years with mild to severe acne-prone skin.

What does the study involve?
Up to 3,100 participants will take part worldwide.

Participants will be assigned to receive either:
A dermocosmetic skincare regimen based on the Eucerin DermoPure range together with sun protection or an active control skincare regimen.

Participants will attend a dermatologist clinic at the start of the study and again after 8 weeks. At these visits, the dermatologist will assess acne severity and count acne lesions.

Participants will:
Use the assigned skincare products at home for 8 weeks, take daily facial photographs and upload them electronically during the treatment period and complete questionnaires about their skin condition, quality of life and satisfaction with the products.

After the 8-week treatment period, participants will enter a maintenance phase lasting up to 10 months. During this time, they will complete monthly questionnaires and submit one facial photograph each month.

Total participation will last approximately 12 months.

What are the possible benefits and risks of participating?
Participants may experience an improvement in their acne and overall skin condition. The findings may help improve understanding of the effectiveness and tolerability of skincare regimens for acne-prone skin.

There is a possibility of side effects or skin reactions associated with the skincare products. Participants will be monitored throughout the study and any adverse events will be recorded.

Where is the study run from?
Multiple dermatology clinics and hospitals in the United Kingdom and other countries.

When is the study starting and how long is it expected to run for?
March 2025 to September 2026.

Who is funding the study?
Beiersdorf, Germany.

Who is the main contact?
Miss Anne-Christin Worthmann, Anne-Christin.Worthmann@Beiersdorf.com

Contact information

Miss Anne-Christin Worthmann
Scientific, Public

Beiersdorf AG, Head Office
Hamburg
22529
Germany

Phone	+49 40 4909 2116
Email	Anne-Christin.Worthmann@Beiersdorf.com

Prof Viktoria Eleftheriadou
Principal investigator

Imperium Medical Limited, 10 Duckery Wood Walk
Birmingham
B43 7DW
United Kingdom

Phone	+44 7912530381
Email	viktoria.eleftheriadou@nhs.net

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Evaluation of a dermocosmetic regimen for acne-prone skin in volunteers with IGA Grades 2-4
Study objectives	To evaluate the efficacy of a dermocosmetic regimen consisting of the DermoPure Probiotic Kit (cleansing gel, cleansing mask, hydrogel and oil suspension with probiotics) and Eucerin Oil Control Sun Protection SPF50+ in subjects with acne-prone skin (IGA grades 2-4), as measured by change in acne lesion count.
Ethics approval(s)	Approved 13/01/2025, North West - Greater Manchester Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 0207 104 8084; gmcentral.rec@hra.nhs.uk), ref: 25/NW/0006
Health condition(s) or problem(s) studied	Subjects with acne-prone skin aged 12-50 years with Investigator's Global Assessment (IGA) grades 2-4, evaluating treatment of mild to severe acne vulgaris.
Intervention	Multicentre, blinded, non-randomised, active-controlled, parallel-group real-world evidence study in participants aged 12-50 years with acne-prone skin (IGA grades 2-4). Participants receive either a DermoPure Probiotic Kit-based dermocosmetic regimen plus sun protection or an active control skincare regimen. Clinical assessments are conducted at baseline and week 8, with participant questionnaires completed at baseline, week 4, week 8 and monthly until month 12. The primary outcome is change in acne lesion count; secondary outcomes include IGA score, participant satisfaction, quality of life, overall skin condition and safety.
Intervention type	Other
Primary outcome measure(s)	Acne lesion count measured using an objective dermatologist-assessed count of inflammatory and non-inflammatory acne lesions on the face at Baseline (week 0) and Week 8; primary endpoint assessed as change from baseline to Week 8
Key secondary outcome measure(s)	Improvement in Investigator's Global Assessment (IGA) score measured using Dermatologist-assessed IGA acne severity score (0-4 scale) at Baseline and Week 8 Subject satisfaction with treatment, including product performance and satisfaction measured using subject self-assessment questionnaires at Week 8 Tolerability and safety measured using incidence and assessment of adverse events (AEs), serious adverse events (SAEs), and adverse product effects at Throughout the study (baseline to Month 12) Overall skin condition measured using Subject self-grading questionnaires of skin condition using rating scales at Baseline, Week 4, Week 8, and monthly during Months 3-12 Quality of life measured using Cardiff Acne Disability Index (CADI) and Eucerin Quality of Life (ELQI) questionnaires at Baseline, Week 4, Week 8, and monthly during Months 3-12
Completion date	30/09/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	12 Years
Upper age limit	50 Years
Sex	All
Target sample size at registration	3100
Total final enrolment	3100
Key inclusion criteria	1. Subjects aged 12-50 years 2. Gender: Male, Female, Diverse 3. Phototype Fitzpatrick I-VI 4. Acne-prone skin with IGA grades 2-4 5. Generally healthy, with intact facial skin except for acne lesions 6. Willingness and ability to sign informed consent 7. Compliance with study rules and schedule
Key exclusion criteria	1. Pregnant or lactating women 2. Damaged facial skin (e.g., sunburn, eczema) 3. Use of topical antibiotics or benzoyl peroxide (BPO) during the study 4. Fungal acne 5. Chronic skin diseases, recent (4 weeks before study start) use of immunosuppressants, corticosteroids, or other treatments that could interfere with study outcomes 6. Any dermatological procedures (e.g., peeling, laser treatments) within 2 months prior to the study 7. Participation in any study within the last 3 months
Date of first enrolment	13/03/2025
Date of final enrolment	14/04/2026

Locations

Countries of recruitment

United Kingdom
England
Austria
Belgium
Brazil
Bulgaria
Chile
Colombia
Croatia
Czech Republic
Ecuador
France
Germany
Hungary
Italy
Malaysia
Mexico
Netherlands
Peru
Poland
Portugal
Serbia
Slovakia
South Africa
Spain
Switzerland
Thailand
Viet Nam

Study participating centres

Chelsea and Westminster Private Dermatology Clinic

369 Fulham Rd
London
SW10 9NH
England

Homerton Hospital

Homerton Row
London
E9 6SR
England

Imperium Medical Ltd

10 Duceery Wood Walk
Birmingham
B43 7DW
England

Miravue Clinic - Sangeeta Punjabi

Spikesbridge Road
Southall
UB1 2AS
England

Nuffield Health Warwick

Gallagher Business Park
Heathcote
CV34 6AD
England

Simon Tso

16 Hillmorton Road
Rugby
CV22 5AA
England

Hospital of St John and St Elizabeth (grove End Road)

60 Grove End Road
London
NW8 9NH
England

Taktouk Clinic

12 Sloane St
London
SW1X 9LJ
England

The Meriden Hospital, Part of Circle Health Group

University Hospital site, Clifford Bridge Rd
Coventry
CV22LQ
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

06/08/2026: Study's existence confirmed by the Health Research Authority (HRA) (UK).