NCT04865094

Brief Summary

To evaluate the photo-protector effect of BC\_3 (E212657) formulated in SPF compared to SPF alone on long-UVA induced pigmentation in healthy volunteers.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

April 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

April 26, 2021

Last Update Submit

April 28, 2021

Conditions

PigmentationRedness

Outcome Measures

Primary Outcomes (2)

  • Biophysical non-invasive assessment of skin color by using Chromameter Post-UVA pigmentation, Erythema

    Delta E calculated value \& ITA°-calculated value, a\* value

    Change from baseline at Day 7

  • Clinical investigator's assessment by using clinical scale

    Visual scoring of pigmentation

    Change from baseline at Day 7

Secondary Outcomes (1)

  • Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance)

    Change from baseline at Day 7

Study Arms (2)

cyclic merocyanine

ACTIVE COMPARATOR

long-UVA absorber

Other: cyclic merocyanine

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

cyclic merocyanineOTHER

long-UVA absorber

cyclic merocyanine
placeboOTHER

placebo

placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female or male volunteer;
  • from 18 to 40 years old;
  • uniform skin color all over on the investigational zones;
  • skin type III or IV according to the Fitzpatrick classification;
  • female of childbearing age using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study);
  • informed about the study objectives and procedures, and able to understand them;
  • willing and able to fulfill the study requirements and schedule.
  • All subjects will have to give their written informed consent

You may not qualify if:

  • having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study;
  • having sunburn (erythema) on the back;
  • dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems);
  • history of skin cancer;
  • history of abnormal response to sun;
  • presence of recent suntan (according to Investigator opinion) or photo-test marks;
  • history of allergy, hypersensitivity, or any serious reaction to any cosmetic product;
  • any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator;
  • unable to be contacted by phone in case of emergency;
  • Deprived of liberty by adjunction or by official decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIDP Biotechnology

Bucharest, 011607, Romania

RECRUITING

Related Publications (1)

  • Marionnet C, de Dormael R, Marat X, Roudot A, Gizard J, Planel E, Tornier C, Golebiewski C, Bastien P, Candau D, Bernerd F. Sunscreens with the New MCE Filter Cover the Whole UV Spectrum: Improved UVA1 Photoprotection In Vitro and in a Randomized Controlled Trial. JID Innov. 2021 Nov 25;2(1):100070. doi: 10.1016/j.xjidi.2021.100070. eCollection 2022 Jan.

    PMID: 35072138DERIVED

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ALINA GHITA, PhD

    CIDP Biotechnology S.R.L

    STUDY DIRECTOR

Central Study Contacts

ALINA GHITA, PhD

CONTACT

0 317 181AlinaNanu@eurofins.com

Study Design

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

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 29, 2021

Study Start

April 29, 2021

Primary Completion

April 29, 2021

Study Completion

April 29, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

RO(1)