Effectiveness and Tolerance of Cicaplast Baume B5 After Superficial CO2 Laser Resurfacing

NCT06467032 | Completed

• 1 other identifier: LRP21007 Cicaplast
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This monocentric, double-blinded, randomized with intra-individual comparisons study is an interventional cosmetic study. The objective is to evaluate the effectiveness of a new formulation on the re-epithelialization kinetic after superficial CO2 laser dermabrasion in comparison to an untreated area.

Conditions

Wound Heal

Keywords

re-epithelialization; superficial CO2 laser resurfacing; Cicaplast Baume B5

Outcome Measures

Primary Outcomes (1)

• wound healing assessment by the Investigator (number of days for complete re-epithelialization)

  assessment on a 6-point scale: 0 (No healing); 1 (Weak healing: \<25% of the lesion area); 2 (Partial healing: between 25 and 50% of the lesion area); 3 (Significant healing: between 50 and 75% of the lesion area); 4 (Almost complete healing: \>75% of the lesion area); 5 (Complete healing).

  from baseline to Day19

Secondary Outcomes (1)

• wound healing assessment by the Investigator (number of days for 25%, 50% and 75% re-epithelialization)

  from baseline to Day19

Study Arms (2)

superficial CO2 laser resurfacing

EXPERIMENTAL

The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product.

Other: superficial CO2 laser resurfacing

Laser untreated side

ACTIVE COMPARATOR

The tested product and comparators are applied twice daily from Day2 to Day18 (except Sundays Day7 and Day14). Each subject receives a total of 30 applications of each tested product.

Other: Laser untreated side

Interventions

superficial CO2 laser resurfacing OTHER

Application of the tested product and comparators on the laser treated side of the back

superficial CO2 laser resurfacing

Laser untreated side OTHER

Application of the tested product and comparators on the laser untreated (control) side of the back

Laser untreated side

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• phototype II and III on the Fitzpatrick scale
• subjects with normal clinical examination and medical history compatible with the study

You may not qualify if:

• subject with underlying pathology that may interfere with the interpretation of the study results (dermatological history of psoriasis, eczema, urticaria... or suspicion/history of allergies to cosmetics), skin abnormality (scars, excessive hair growth, tattoos...) in the test areas (back, midline), systemic pathology
• subject with excessive exposure to natural (sun) or artificial (tanning salon) ultraviolet light (UV) 4 weeks prior to the initial visit or who anticipates such exposure during the study

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CPCAD

Nice, France

Location

Study Officials

• Catherine Queille-Roussel

  Centre de Pharmacologie Clinique Applique a la Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: January 16, 2023
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

FR (1)