NCT04878692

Brief Summary

It is important for patients treated with anti-EGFR therapies to get access to cosmetic options to preserve their skin condition during treatment. Anti-EGFR therapies are known to fragilize epidermis and to provoke rashes; which often lead to treatment discontinuation. The aim of this study is to demonstrate that the Onco-Rash cream is able to preserve skin condition without side effects. Decreasing skin toxicity is expected to improve patients' life and facilitate treatment follow-up.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

May 4, 2021

Last Update Submit

May 4, 2021

Conditions

Carcinoma, Non-Small-Cell LungColorectal NeoplasmsHead and Neck Neoplasms

Keywords

Skin Rashanti-EGFR therapyCosmetic ProductAcneCancer patients

Outcome Measures

Primary Outcomes (1)

  • Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale).

    Measurement of Onco-Rash percentage of failure by counting the number of patients for whom a skin rash with a grade ≥ 2 (NCI-CTCAE scale) will occur between 0-6 weeks after the start of the anti-EGFR treatment. The introduction of an anti-inflammatory, a calming or an antibiotic treatment for acne will also be considered as failure.

    6 weeks after the start of the anti-EGFR treatment.

Secondary Outcomes (3)

  • Timing of apparition of grade 1, 2 or ≥ 2 skin eruption: number of days between the start of the anti-EGFR treatment and the apparition of a skin eruption.

    6 weeks after the start of the anti-EGFR treatment.

  • Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption

    6 weeks after the start of the anti-EGFR treatment.

  • Percentage of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been introduced

    6 weeks after the start of the anti-EGFR treatment.

Study Arms (2)

Onco-Rash arm

EXPERIMENTAL

In this arm label, patients will apply the Onco-Rash cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. This arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.

Drug: Application of Onco-Rash cream

Onco-Neutre arm

PLACEBO COMPARATOR

In this arm label, patients will apply the Onco-Neutre cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. Onco-Neutral cream will be used as an experimental comparator to Onco-Rash cream. This arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.

Drug: Application of Onco-Neutre cream

Interventions

Application of Onco-Rash creamDRUG

The cream "Onco-Rash" will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.

Onco-Rash arm
Application of Onco-Neutre creamDRUG

The cream "Onco-Neutre" will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.

Onco-Neutre arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient \> 18 years old
  • Patient naive from anti-EGFR treatment (gefitinib, erlotinib, afatinib, cetuximab panitumumab, osimertinib, alectinib et crizotinib, etc).
  • NSCLC (non-small cell lung cancer) patients eligible to anti-EGFR as first line treatment (gefitinib, erlotinib,afatinib, etc)
  • Colorectal cancer patients eligible to anti-EGFR as first line treatment (cetuximab, panitumumab,….)
  • Head and Neck/ENT (Ear, Nose Troat) cancer patients eligible to anti-EGFR as first line treatment (cetuximab,…)
  • Signed informed consent
  • Social security affiliation

You may not qualify if:

  • Pregnant or Breastfeeding patient
  • Patient in age to procreate without an efficient contraceptive method
  • Patient with previous experience of allergic or irritative contact dermatitis to components of the studied product
  • Patient with dermatologic conditions that cannot permit the study of skin toxicity of anti-EGFR
  • Participation to another interventional study
  • Patient with an altered ECOG (Eastern Cooperative Oncology Group) state ( \>2)
  • Patient deprived of liberty or subjected to guardianship
  • Impossibility to track and follow patient for geographical, social or psychiatric reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungColorectal NeoplasmsHead and Neck NeoplasmsExanthemaAcne Vulgaris

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsSebaceous Gland Diseases

Study Officials

  • Julien PERON, MD

    Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien PERON, MD

CONTACT

478862339julien.peron@chu-lyon.fr

Anne-Sophie BELMONT

CONTACT

0478864195anne-sophie.belmont@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 7, 2021

Study Start

June 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 7, 2021

Record last verified: 2021-05

Locations

FR(1)