NCT05786976

Brief Summary

The aim of this study is to compare the efficacy and tolerability of a cosmetic product to one that is already available on the market (benchmark product). Efficacy is assessed by instrumental measurements of skin condition, clinical examinations, and questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 11, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

29 days

First QC Date

February 15, 2023

Last Update Submit

March 27, 2023

Conditions

Atopic DiathesisEczema-Prone Skin

Outcome Measures

Primary Outcomes (6)

  • Mean change from baseline in transepidermal water loss (g/m2h)

    29 days

  • Mean change from baseline in skin redness by Chromameter

    29 days

  • Mean change from baseline in skin hydration (Skin capacitance by Corneometer [a.u.])

    29 days

  • Changes from baseline in local SCORAD (Scoring Atopic Dermatitis, min=0, max=3; 3=worse outcome) in children

    29 days

  • Changes from baseline in objective dermatological evaluation of skin status (erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, weeping) by dermatologist

    29 days

  • Changes from baseline in POEM (Patient-oriented eczema measure, min=0, max=28; 28=worse outcome)

    29 days

Secondary Outcomes (5)

  • Change from baseline in the scoring of subjective dermatological evaluation via questionnaire (adults) (min=0, max=3; 3=worse outcome)

    29 days

  • Evaluation of products traits via questionnaire (20 questions with different answers, no scales)

    Day 1, after first application

  • Evaluation of products traits via questionnaire (20 questions with different answers, no scales)

    8 days

  • Evaluation of products traits via questionnaire (20 questions with different answers, no scales)

    29 days

  • Safety of BNO 3732 measured by reported Adverse Events

    until day 29

Study Arms (2)

Lotion BNO 3732 for topical care

EXPERIMENTAL
Other: Lotion BNO 3732

Body Lotion Benchmark product for topical care

ACTIVE COMPARATOR
Other: Body Lotion Benchmark product

Interventions

Lotion BNO 3732OTHER

Crem body lotion twice daily

Lotion BNO 3732 for topical care
Body Lotion Benchmark productOTHER

Crem body lotion twice daily

Body Lotion Benchmark product for topical care

Eligibility Criteria

Age6 Months - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent of the subject to participate in the study, or, for underage subjects of the parents/ legal guardians to let their child participate in the study
  • Willingness to actively participate in the study and to come to the scheduled visits or, for underage subjects, willingness of the parents/ legal guardians to actively support their child's participation in the study and to come to the scheduled visits with their child
  • Female and/or male
  • Children from 6 months to 14 years of age and adults between 18 and 65 years of age
  • Eczema-prone skin and atopic diathesis, diagnosed by the dermatologist

You may not qualify if:

  • Female subjects: pregnancy or lactation
  • Drug addicts, alcoholics
  • AIDS, HIV positive or infectious hepatitis
  • Conditions which exclude a participation or might influence the test reaction/evaluation
  • Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
  • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
  • Insulin-dependent diabetes mellitus
  • Documented allergies to cosmetic products and/ or ingredients, skin care and/or skin cleansing products
  • Wounds, moles, tattoos, scars, excessive hair growth, etc. at the test area that could influence the investigation
  • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
  • Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS proderm GmbH

Schenefeld, 22869, Germany

Location

Study Officials

  • Sabrina Laing, Dr.

    proDERM GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: intra-individual comparison
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 28, 2023

Study Start

January 11, 2022

Primary Completion

February 9, 2022

Study Completion

February 9, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

DE(1)