Exploring new dimensions in

rosacea management

Global Scientific Committee (GSC) Meeting Report

Meeting date: 3 July 2023 14:00–16:00 SST

Report Version: V1.0

GSC, Global Scientific Committee; SST, Singapore Standard Time.

July 2023
Executive summary
Expert presentation discussions Content outline discussions

• The consensus of the group agreed that patients generally are tired of using topical agents • The GSC recommend considering the creation of ‘talking head’ videos to accompany the
and often are non-adherent due to a lack of improvement in their daily QoL. Perhaps, REACH narrative, which highlight and visualize how the pathway is received by patients and
combination treatments could help restore patient confidence that they are treating both the where improvements can be made in order to achieve more successful outcomes
underlying causes as well as symptom management at skin surface level?
• The GSC recommend the creation of an abridged version of the pathway which covers ~5
• The REACH narrative should aim to encourage HCPs to ask more questions surrounding key areas and then directs the reader to additional information if required – more likely to gain
symptomology and general QoL in order to better diagnose and treat rosacea and any attention if something is simple and accessible
secondary dermatoses. This could be in the form of pre-appointment questionnaires, or a
• Use this narrative as an opportunity to change the terminology around treatment of rosacea to
standardized dermatology triage completed by patients
be more targeted and symptom-driven, with greater emphasis on improving patient QoL
• It is important to facilitate improved collaboration of dermatologists with histopathology teams
• The group suggested that REACH should give greater attention to the possibility of multiple
to gain better insights and understanding of a patient’s disease state for more accurate
diagnoses, which can then help govern more appropriate treatment decisions for each patient
diagnosis, to assist individualized patient treatment plans and communicate realistic
– including the role or benefit of combination treatments
treatment goals for each patient
• REACH could also address the different treatment modalities available and differentiate
• The GSC thought it was worth citing the use of combination treatments to tackle the
those that are most likely to allow patients to achieve ‘clear’ thus allowing the HCP to set
inflammatory innate immune responses in the pathophysiology of rosacea
realistic goals for individual patients
• The REACH narrative should encourage the analysis and further study of ROS in patients
• Consider designing the treatment narrative to complement existing pathways – what is failing
with rosacea to gain a wider understanding of their role in rosacea pathophysiology and
in what currently exists? This manuscript could be the simple version that helps clarify a
alternative treatment options
treatment algorithm for HCPs, which can then direct them to existing material that provides
• The GSC believe there should be greater emphasis on treating symptomology to reduce greater in-depth detail
flares, improve patient QoL and foster better treatment adherence. Further encouragement of
• Consider the place triggers hold in the REACH narrative – could this be a section on its own
HCPs to ask patients QoL-related questions to gain a fuller picture of the patient’s disease
or a running theme through the narrative that should be given more attention?
state was thought necessary

GSC, Global Scientific Committee; HCP, healthcare professional; QoL, quality of life; REACH, Rosacea – Expert Advice on Combined and Holistic approaches; ROS, reactive oxygen species.

CONFIDENTIAL 2
Contents
Content Page number
Attendees 5
Meeting objectives 6
On-the-day agenda 7
How to navigate this report 8
Speaker presentation summaries
Insights on the rosacea toolkit and longitudinal care approach for rosacea management 10
Insights on rosacea in skin of color 11
Insights on rosacea management for treatment in Demodex mites 12
Insights on sensitive skin: Current understanding, new findings and new tool for
13
diagnostic
Summaries of GSC discussions on the content of the REACH manuscript
Longitudinal rosacea pathway framework 15
Discussions on the REACH longitudinal rosacea pathway 16–19
Target journals for the REACH longitudinal rosacea management outline 20
Action point summary 21

REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 3
Attendees, agenda
and objectives
Exploring new dimensions in rosacea management
Attendees
GSC co-Chair Guest speakers
Professor Martin Schaller, Professor and Assistant Medical Director, Department of Dermatology, Dr Johannes Dayrit, Associate Professor and Consultant
Eberhard Karls University, Tübingen, Germany in Dermatology, De La Salle Medical and Health Sciences
Institute, Dasmariñas, the Philippines
GSCmembers
Galderma
Dr Belinda Welsh, Founding Director of Complete Skin Specialists, Sunbury, VIC, Australia
Dr Rajeev Chavda, MD, Head, Global Medical Affairs for
Dr Luiz Mauricio Costa Almeida, Department of Dermatology, Faculdade de Ciências Médicas
Inline Prescription and Phase 3b/4 strategy
de Minas Gerais, Belo Horizonte, Brazil
Elgiz Süzer, Global Franchise Head, Rosacea
Professor Jerry Tan, Adjunct Professor of Internal Medicine and Dermatology,
Western University, Ontario, Canada Gerhard Mule, SVP & Head of Global Product Strategy
Professor Thomas Dirschka, Dermatologist, Dermato-oncologist, CentroDerm Clinic Wuppertal Nadège Lachmann, Global Head of Skin Science,
and Faculty of Health, University of Witten-Herdecke, Germany Galderma
Professor Soyun Cho, Professor and Head of Dermatology at Seoul National University, Sciterion
Boramae Medical Center, Korea
Dr Hannah Noel, Scientific Director
Professor Wioletta Barańska-Rybak, Professor of Dermatology, Department of Dermatology,
Venereology and Allergology, Medical University of Gdansk, Poland Danielle Homewood, Senior Account Manager

Dr James Del Rosso, Head of JDR Dermatology Research Center, Las Vegas, Nevada, USA Dr Tasha Chauhan, Medical Writer

Dr Julie Harper, Founding Director of the American Acne and Rosacea Society,
Clinical Associate Professor of Dermatology at the University of Alabama-Birmingham, USA

GSC, Global Scientific Committee.

CONFIDENTIAL 5
Meeting objectives
The GSC members came together to discuss the content outline for the REACH narrative, as well as data and findings presented by
Professor Jerry Tan, Dr Johannes Dayrit, Professor Martin Schaller and Dr Nadège Lachmann. The overall objective was to review and refine
the proposed content outline for the REACH narrative and to use the presentations to offer further insight and identify any additional points to
be included in the manuscript.

1 2 3
Explore Review Refine
Implications for the Content outline review
Presentations by: rosacea narrative and refinement

Professor Jerry Tan Are there elements of Professor We will examine the patient
Rosacea toolkit and longitudinal care Tan’s, Dr Dayrit’s, Professor progress points along the
approach for rosacea management
Schaller’s and Dr Nadège longitudinal pathway and
Dr Johannes Dayrit Lachmann’s presentations that establish which GSC members
Rosacea in skin of color ought to be included within the could be considered to review
pathway or REACH and provide case studies at
Professor Martin Schaller content outline? each pillar
Rosacea management for treatment in
Demodex mites

Dr Nadège Lachmann
Sensitive skin

GSC, Global Scientific Committee; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 6
 Exploring new dimensions in rosacea management
On-the-day Agenda
Time Session Lead

Rajeev Chavda, MD, Head Global Medical Affairs for Inline Prescription and Phase
14:00–14:10 Welcome, introductions and meeting objectives 3b/4 Strategy, Galderma
Hannah Noel, PhD, Scientific Director, Sciterion
PART 1: Presentations from GSC members and Galderma

14:10–14:15 Presentations: Introduction and rationale Presentation by Hannah Noel

Presentation by Professor Jerry Tan, Adjunct Professor of Internal Medicine

14:15–14:30
Rosacea toolkit and longitudinal care approach for rosacea management and Dermatology, Western University, Ontario, Canada
(15-min presentation)

Presentation by Dr Johannes Dayrit, Associate Professor and Consultant in

14:30–14:45
Rosacea in skin of color Dermatology, De La Salle Medical and Health Sciences Institute, Dasmariñas,
(15-min presentation)
the Philippines

14:45–15:00 Presentation by Professor Martin Schaller, Professor and Assistant Medical Director,
Rosacea management for treatment in Demodex mites
(10-min presentation, 5-min Q&A) Department of Dermatology, Eberhard Karls University, Tübingen, Germany

15:00–15:20
Sensitive skin Presentation by Nadège Lachmann, Global Head of Skin Science, Galderma
(20-min presentation)

15:20–15:25 Presentations: Summary Facilitated by Hannah Noel

PART 2: Content outline review and refinement

Presentation and open discussion facilitated by Hannah Noel, PhD
15:25–15:35 Implications for the rosacea management narrative
and Rajeev Chavda
1 Presentation and open discussion facilitated by Hannah Noel, PhD
1 15:35–15:55 Content outline review and refinement
and Rajeev Chavda
J
U Hannah Noel
15:55–16:00 Next steps and close
L Rajeev Chavda
Y
2 GSC, Global Scientific Committee.
0
CONFIDENTIAL 7
2
3
 How to navigate this report
Report contents and reader guidance

This section provides a

This pull-out box
short summary of each
topic discussed during highlights the action
the meeting and points identified during
feedback provided by the meeting to address
the GSC members. unmet needs in
long-term rosacea
The order being; speaker
management and will
presentations (p10–13)
REACH publication outline shape the key themes
discussions (p15–19) and of the REACH
finally potential target publication
journals and action points
(p20–21)

GSC, Global Scientific Committee; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 8
Speaker presentation
summaries
Insights on the rosacea toolkit and longitudinal care approach
for rosacea management
Presentation by Professor Jerry Tan

Professor Tan discussed how adopting a phenotype-based approach may
facilitate better patient-centered management of rosacea and how both the
ROSCO expert panel and the AARS had used this approach to develop rosacea
treatment algorithms.
The importance of maintenance therapy once treatment objectives have been
achieved was emphasized. Professor Tan recommended that physicians first
establish a diagnosis, specifying rosacea-associated presenting features. He
explained how discussing potential QoL impact and overall goals facilitates a
realistic treatment regimen.
GSC members agreed that a negative perception of a ‘chronic’ diagnosis exists but
articulating rosacea as ‘chronic but manageable’ would help alleviate patient
concerns.
Dr Welsh highlighted the need to cover differential diagnosis, for example, sun
damage, and where the actual cause of erythema is something other than rosacea,
which will alter treatment decisions.
Action/consideration points
• Ideally, the narrative should house a longitudinal pathway, which
addresses why patients who reach IGA ‘clear’ could still suffer with
flares and issues with QoL
• Consider that patients generally are tired of using topical agents and
are often non-adherent due to a lack of improvement in their daily QoL.
Perhaps, combination treatments could help restore patient confidence
that they are treating both the underlying causes as well as symptom
management at skin surface level?
• Various factors should be considered when devising a rosacea
treatment plan, including formulations, combination treatments and
treatment duration

Dr Del Rosso suggested avoiding terminology such as ‘first-line’ and ‘second-line’

as this is not always directly translatable in clinic and is subject to what disease
stage the patient presents with.

AARS, American Acne and Rosacea Society; GSC, Global Scientific Committee; IGA, Investigator’s Global Assessment; QoL, quality of life; ROSCO, ROSacea COnsensus.

CONFIDENTIAL 10
Insights on rosacea in skin of color
Presentation by Dr Johannes Dayrit
Dr Dayrit presented findings from his studies of rosacea in the Filipino population.
His study corroborated previous evidence that rosacea is under-diagnosed in skin
of color, despite global advancements in symptom recognition. He also found that
many rosacea patients within the study population had not heard of the condition
before their diagnosis.
Providing a deeper insight into the histopathology of rosacea in skin of color was
thought useful as facial erythema is difficult to detect in darker skin phototypes,
and papules and pustules are often misdiagnosed as acne, for example. Professor
Dirschka acknowledged histopathology could use more attention, as evidenced by
Professor Dayrit’s data.
Dr Del Rosso highlighted there had been a large community-based trial in the US
evaluating sub-antibiotic dose doxycycline in ~2,000 patients with PPR. The
investigators reported 20% of patients were FST IV–VI, which was a surprise at the
time. He remarked: ‘In patients where we cannot really see transient facial
erythema due to darker skin phototypes, are there specific symptoms that can tip
us off to a diagnosis of rosacea?’’
Dr Dayrit agreed there was a need for HCPs to ask more questions surrounding
symptomology as detection of erythema, and indeed rhinophyma, in this population
can be tricky. However, he noted that patients often complain about heat.
FST, Fitzpatrick skin type; HCP, healthcare professional; PPR, papulopustular rosacea; QoL, quality of life; US, United States.
CONFIDENTIAL
Action/consideration points
• Encourage HCPs to ask more questions surrounding symptomology
and general QoL in order to better diagnose and treat rosacea and
any secondary dermatoses. This could be in the form of pre-appointment
questionnaires, or a standardized dermatology triage completed
by patients
• Facilitate improved collaboration of dermatologists with histopathology
teams to gain better insights and understanding of a patient’s disease
state for more accurate diagnosis, to assist individualized patient
treatment plans and communicate realistic treatment goals for
each patient
• To highlight location of histopathology samples can influence the results
seen (e.g., samples closer to papules may be different to clear skin
samples)
• Encourage further research to better understand rosacea in skin of color
and address misperceptions and potential misdiagnosis
11
Insights on rosacea management for treatment in
Demodex mites
Presentation by Professor Martin Schaller

Professor Schaller explained that the connection between rosacea and Demodex Action/consideration points
mites had been established around 25 years ago. Demodex can play a central
role in the disease pathophysiology. Indeed, mite proliferation is linked to • Provide rationale for the use of histopathology in aiding the development
immunosuppression or immunostimulation, which in turn could lead to
of individualized treatment plans to help achieve patient goals. The GSC
inflammatory responses and ultimately erythema.
thought it was worth citing the use of combination treatments to tackle the
Histopathology was highlighted as a useful tool in providing evidence of Demodex inflammatory innate immune responses in the pathophysiology of rosacea
involvement in tissue invasion within inflammatory processes in rosacea
pathogenesis. • Consider histopathology within the REACH pathway as a tool for
diagnosis and treatment decisions
The findings of Professor Schaller’s independent study, investigating the potential
of ivermectin 1% (OD) cream in improving rosacea-associated erythema and • Topical agents are useful therapeutic interventions in the long-term
invisible symptoms, were shared. The study combined established questionnaires suppression of rosacea symptoms and in the management of
with a novel photography and analysis tool Scarletred®Vision. Improvement of Demodex-related skin conditions
inflammatory lesions such as papules and pustules, as well as vascular symptoms
such as erythema and telangiectasia, and non-visible discomfort such as burning
and stinging were all improved with 1% ivermectin.

Professor Schaller concluded that symptomatic and QoL improvements can be

attained alongside IGA 0 through long-term maintenance therapy with ivermectin
1% cream. This maintenance may follow intensive treatments such as laser
therapy or skin barrier therapy and supports long-term management of
Demodex-related skin conditions.

GSC, Global Scientific Committee; IGA, Investigator’s Global Assessment; OD, once daily; QoL, quality of life; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 12
Insights on sensitive skin: Current understanding, new findings
and a new diagnostic tool
Presentation by Dr Nadège Lachmann

Dr Lachmann highlighted the need to address sensitive skin as a separate Action/consideration points
condition (apart from associated dermatoses) as evidenced by increasing proof of
neurogenic inflammation and morphological changes seen in sensitive skin. The • Potential inclusion of the Sensitive Scale-10 as a tool in the longitudinal
Sensitive Scale-10 was profiled as a new validated tool for the diagnosis of
management of rosacea
sensitive skin in patients with rosacea.
• Explain how a secondary diagnosis of sensitive skin (identified using such
Dr Del Rosso expressed surprise at the results on nerve and vascular density in
a tool) can warrant complementary treatment to rosacea and support
sensitive skin and suggested a further study to verify these findings with a larger
patient population. better patient outcomes

In Professor Dirschka’s experience he found that women identify with sensitive • Encourage the analysis and further study of ROS in patients with rosacea
skin more commonly than men, to which Dr Lachmann suggested the Sensitive to gain a wider understanding of their role in rosacea pathophysiology
Scale-10 should help eliminate this subjectiveness. and alternative treatment options

Dr Almeida commented that rosacea is an inflammatory condition, which can lead • Emphasise treating symptomology to reduce flares, improve patient QoL
to sometimes invisible inflammation. Professor Tan continued this point, suggesting and foster better treatment adherence. Further encourage HCPs to ask
that due to innate immune activation, labs should start measuring ROS below the patients QoL-related questions to gain a fuller picture of the patient’s
basal keratinocyte layer as this could be the ‘missing link’ in rosacea treatment.
disease state
Dr Welsh suggested that managing swelling and vascular control could reduce the
occurrence of flushes, especially in the teenage population where visual symptoms
can be linked to stress and migraines.

HCP, healthcare professional; QoL, quality of life; ROS, reactive oxygen species.

CONFIDENTIAL 13
Summaries of GSC
discussions on the
content of the
REACH manuscript
 Longitudinal rosacea pathway framework

Patient Patient Patient Patient Patient

progress progress progress progress progress
point point point point point

Case study? Case study? Case study? Case study?

SELF-
MANAGEMENT
AND ENTRY TREATMENT PATIENT
DIAGNOSIS MAINTENANCE
INTO THE SELECTION SATISFACTION
MEDICAL
PATHWAY

Step-down/step-up
Rosacea returns to unacceptable level for patient

CONFIDENTIAL 15
REACH longitudinal rosacea pathway
REACH PILLAR 1: Self-management, entry into the medical pathway and diagnosis

GSC feedback: Action/consideration points

Dr Del Rosso suggested the pathway should be provided as a single
sheet for easier comprehension by HCPs, similar to the existing
7-question tool for atopic dermatitis. In his opinion, a simple, validated
pathway, which included a point scale would be received well. As
many nurses and primary care providers do not have specific nor
dermatology training, it is important that the pathway is easy to
interpret and encourages users to ask the correct questions at
each point.
Professor Dirschka highlighted the need to consider the possibility of
more than one diagnosis in the pathway, and to also format the
pathway so that it encompasses 5 main points, which then lead on to
further information, should the reader require it.
• Consider the creation of ‘talking head’ videos to accompany
the REACH narrative, which highlight and visualize how the
pathway is received by patients and where improvements can
be made in order to achieve more successful outcomes
• Create an abridged version of the pathway, which covers ~5
key areas and then directs the reader to additional information
if required – more likely to gain attention if something is simple
and accessible, especially amongst primary care providers
which will in turn will increase use of the pathway and be more
likely to encourage a behavioural change

Including key questions aimed at differentiating rosacea from other

dermatoses would be helpful within the pathway, thought Dr Welsh,
with reference to treatment ‘buckets’, e.g. topicals.

GSC, Global Scientific Committee; HCP, healthcare professional; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 16
REACH longitudinal rosacea pathway
REACH PILLAR 2: Treatment selection

GSC feedback: Action/consideration points

Dr Harper expressed interest in the possibility of changing the • Use this narrative as an opportunity to change the
language used to help HCPs think more about preventing symptoms terminology around treatment of rosacea to be more targeted
along a phenotypic treatment plan for rosacea.
and symptom-driven, with greater emphasis on improving
Additionally, Dr Harper mentioned inclusion of trigger avoidance was patient QoL
which was agreed with by Dr Cho.
• Give greater attention to the possibility of multiple diagnoses,
Dr Del Rosso suggested inclusion and definition of which modalities which can then help to govern more appropriate treatment
are going to achieve ‘clear’ for patients, and what is the most efficient decisions for each patient – including the role or benefit of
path to get to ‘clear’. combination treatments

GSC, Global Scientific Committee; HCP, healthcare professional; QoL, quality of life; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 17
REACH longitudinal rosacea pathway
REACH PILLAR 3: Patient satisfaction

GSC feedback: Action/consideration points

Dr Harper suggested recording interactions between HCPs and • Address the different treatment modalities available and
patients, then ask the patient what they remember and see what differentiate those that are most likely to allow patients to
resonates with the patient the most – as a potential learning tool. achieve ‘clear’, and then define whether this is possible for
the individual patient
Dr Welsh emphasized that there is much variability amongst patients,
and many patients have the possibility of achieving good results,
especially if the psychological element can be addressed.

GSC, Global Scientific Committee; HCP, healthcare professional; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 18
REACH longitudinal rosacea pathway
REACH PILLAR 4: Maintenance

GSC feedback: Action/consideration points

Dr Welsh emphasized that the need for maintenance needs to be • Consider designing the treatment narrative to complement
driven from a patient perspective. existing pathways – what is failing in what currently exists?
This manuscript could be the simple version that helps clarify
Dr Harper suggested how HCPs could consider making rosacea
‘triggerless’. When a patient improves, do their triggers go away? a treatment algorithm for HCPs, which can then direct them to
Could this be defined as an outcome for patients? Triggers in rosacea existing material that provides the greater in-depth detail
are linked to inflammation, so could we include triggers in a different
way to the way they are now? Ask patients, ‘how important is that • Consider the place triggers hold in the REACH narrative –
trigger in your QoL?’. Dr Almeida expanded on this point and supported could this be a section on its own or a running theme through
asking patients if they are willing to give up their triggers. Professor the narrative that should be given more attention?
Dirschka highlighted that the burden of disease was often replaced by
the burden of restrictions.

Professor Tan highlighted the fact that pathways have been developed
previously, so we need to address the bigger picture: 1) Is it rosacea?
2) What are the symptoms? 3) What are your goals? 4) What treatment
will achieve those goals? Keep it simple and the manuscript can direct
HCPs to further details.

GSC, Global Scientific Committee; HCP, healthcare professional; QoL, quality of life; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 19
Target journals for the REACH longitudinal rosacea
management outline
GSC members to consider most appropriate journal for publication submission

Action/consideration points
Journal title Impact
factor • GSC members to independently review possible target journals
Acta Dermato-Venereologica 3.875 and provide their top 2 options via a poll

Dermatologic Therapy 3.858 • Galderma to independently review possible target journals and
decide which will be the most appropriate
Dermatological Reviews 0.2

American Journal of Clinical Dermatology 7.403

Journal of Clinical and Aesthetic Dermatology 0.483

GSC, Global Scientific Committee; REACH, Rosacea – Expert Advice on Combined and Holistic approaches.

CONFIDENTIAL 20
Action point summary
Expert presentation discussions
• Give emphasis to combination treatments and inform HCPs on the benefits
of better educating patients on the benefits of a dual-action treatment plan
to improve patient adherence to even topical prescriptions, which they
previously may not have been satisfied with
• Make QoL a central concern for HCPs through an increased attention
to symptomology
• Use the REACH narrative to assist primary care providers in a more
thorough triage of patients to assist dermatologists with diagnosis
• Address the importance of dermatologists collaborating with histopathology
teams to: bridge the gap and allow for better insights and understanding of
a patient’s disease state for more accurate diagnosis; assist individualized
patient treatment plans; and communicate realistic treatment goals for
each patient
• Encourage HCPs to ask QoL-related questions to gain a fuller picture of
their patient’s disease state
• Gain a wider understanding of the role of ROS in rosacea pathophysiology
and alternative treatment options, using the REACH narrative to encourage
the analysis and further study of ROS in patients with rosacea
GSC, Global Scientific Committee; HCP, healthcare professional; QoL, quality of life; REACH, Rosacea – Expert Advice on Combined and Holistic approaches; ROS, reactive oxygen species.
CONFIDENTIAL
Content outline discussions
• Identify and communicate the ~5 key areas of rosacea management and use
the REACH narrative to direct the reader to additional information if required
• Acknowledge that a longitudinal pathway is more likely to gain attention if it is
simple and accessible for HCPs to implement in their daily clinical practice to
enact a direct improved response for the patients
• Modify the general terminology around treatment of rosacea to be targeted
and symptom-driven, with greater emphasis on improving patient QoL
• Utilize the REACH narrative to give greater attention to the possibility of
multiple diagnoses, which can then help to govern more appropriate
treatment decisions for each patient – including the role or benefit of
combination treatments
• Consider the creation of ‘talking head’ videos to accompany the REACH
narrative, which highlight and visualize how the pathway is received by
patients and where improvements can be made in order to achieve more
successful outcomes
• Consider the place triggers hold in the REACH narrative – could this be a
section on its own or a running theme through the narrative that should be
given more attention?
21