A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema

Launched by DERMAL LABORATORIES LTD · Jun 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a product called Doublebase Once works for treating atopic eczema, which is a skin condition that causes dryness and itching. The study will last for 4 weeks and involves patients of all ages who already use skin moisturizers (called emollients) for their eczema. Participants will switch to using Doublebase Once once a day for the duration of the study. Throughout the trial, researchers will assess the severity of eczema using a scoring system and gather feedback through questionnaires. A small group of adult participants will also have their skin hydration measured to see how well the product helps moisturize the skin.

To take part in this study, participants need to have a history of atopic eczema and a certain level of severity. They should currently be using emollients and be willing to use Doublebase Once as their only moisturizer for 4 weeks. Participants cannot be using antibiotics or other specific treatments for eczema during the trial. Additionally, they should be able to read and understand the study’s information in English. Throughout the trial, participants can expect to have their eczema evaluated and may have photos taken to track any changes in their skin condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ii) Patients with atopic eczema (personal history or combined personal and familial atopy), of any severity in accordance with the NICE categorisation set out in the table below.
• • iii) Baseline SCORAD assessment score of at least 15. iv) Patients or their parents/ legal guardians must be able to read and understand the patient information sheet and sign the Consent Form/Assent Form.
• • v) Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s).
• • vi) Patients who are not currently using systemic or topically applied antibiotics or Doublebase Once.
• • vii) Patients who are willing to use Doublebase Once, once daily, as their only leave-on emollient, for 4 weeks.
• • viii) Patients who are willing to continue to use their standard cleansing regime and/or Doublebase Once as a soap substitute for the duration of the study.
• Additional inclusion criterion for subgroup for skin hydration assessments:
• • i) Baseline corneometry measurement of ≤40 arbitrary units.
• Exclusion Criteria:
• • i) Are currently using or have used in the previous month, any systemic or topically applied antibiotics or Doublebase Once for their atopic eczema.
• • ii) Have a known history of intolerance or skin sensitivity to any of the ingredients of Doublebase Once (as identified on the patient information sheet and product labelling), or similar products.
• • iii) Currently participating in any other ongoing research studies or have participated in a study in the previous 30 days.
• • iv) Patients, or their parents/ legal guardians, who may have difficulties completing the questionnaire, which will be written in English only.
• • v) Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
• • vi) Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their ability to participate in the study.