Evaluation of the Tolerance of the Medical Device RL3010A - DP0378 in Children and Adults Presenting a Superficial Wound After a Dermatological Procedure

NCT06016803 | Completed DMC

• 1 other identifier: RL3010A2022001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The CE-marketed medical device class IIa RL3010A - DP0378 developed by Pierre Fabre Laboratories is indicated in the treatment of superficial wounds and abrasions. It forms a protective layer on the surface of wounds maintaining a moist environment improving the healing process thanks to its moisturizing and film-forming effect. Through this study, the overall tolerance of the medical device will be evaluated in subjects presenting a superficial wound after having undergone a dermatological procedure as cryotherapy, laser (laser Nd Yag, fractional laser C02), Intense Pulse Light (IPL) or skin lesion excision for which stitches were removed.

Conditions

Skin Abrasion; Superficial Wound

Keywords

Wound healing; Medical device

Outcome Measures

Primary Outcomes (1)

• To assess the global tolerance of the medical device RL3010A - DP0378 in subjects presenting a superficial wound after having undergone a dermatological procedure, after 7 days of twice daily applications under normal conditions of use

  Global tolerance with 5 levels ranked from best to worst : Excellent (No functional nor physical signs related to the investigational product observed or reported by the subjects) - Very good - Good - Moderate - Bad

  Day 8

Secondary Outcomes (7)

• To assess the evolution of the physical signs of local tolerance at the site of product application on the wound

  Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.

• To assess the evolution of the functional signs of local tolerance at the site of product application on the wound

  Day 1 before and immediately after the test product application (10 to 30 minutes), at Day 3 and at Day 8.

• To assess the repairing efficacy of the product

  Day 3 and Day 8

• To assess the soothing efficacy of the product

  Day 3 and Day 8

• To assess the soothing efficacy of the product

  Day 1 before and immediately after the test product application, at Day 3 and at Day 8

Study Arms (3)

Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation

EXPERIMENTAL

Group applying the tested medical device

Device: Cicatryl (RL3010A - DP0378)

Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications

EXPERIMENTAL

Group applying the tested medical device

Device: Cicatryl (RL3010A - DP0378)

Subjects having undergone a skin lesion excision for which stitches were removed

EXPERIMENTAL

Group applying the tested medical device

Device: Cicatryl (RL3010A - DP0378)

Interventions

Cicatryl (RL3010A - DP0378) DEVICE

Tested product is applied twice a day. The maximum duration of application is 7 days.

Subjects having undergone a Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation; Subjects having undergone a Laser or IPL procedure for dermatological or aesthetical indications; Subjects having undergone a skin lesion excision for which stitches were removed

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who just undergone (the same day) a dermatological procedure, done according to the investigator's usual practices:
• Group 1: Cryotherapy for benign cutaneous lesions, warts, or hyperpigmentation
• Group 2: Laser (laser Nd Yag, fractional laser C02) or Intense pulse Light (IPL) procedure for dermatological or aesthetical indications (including tattoo removal and depilation)
• Group 3: Skin lesion excision for which stitches were removed
• Subject with a superficial wound after the dermatological procedure

You may not qualify if:

• Criteria related to the skin condition :
• Subject having a skin disease, skin abnormalities, or dermatological condition on the studied area other than the indication of the dermatological procedure liable to interfere with the study assessments (including infectious or inflammatory dermatosis, photodermatosis, etc.)
• Subject with a known history of allergy or contact dermatitis caused by any of the ingredients of the tested product, antiseptic, dressing or latex (if used by the center)
• Subject with healing disorders
• Subject with coagulation disorders
• Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
• Other acute, chronic or progressive disease or medical history considered by the investigator hazardous for the subject or incompatible with the study or liable to interfere with the study assessments
• Criteria related to treatments and/or products :

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dermscan Poland

Gdansk, Poland, 80288, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 30, 2023
• Study Start: August 30, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

PL (1)