Evaluation of Efficacy and Tolerance of Crystal Peel in the Treatment of Adults Presenting Facial Mild Acne

NCT05821296 | Completed Results

• 1 other identifier: 22E2387
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional, confirmatory and post market study is to evaluate the efficacy and clinical performance of Crystal Peel in adults suffering mild facial acne vulgaris. The principal and secondary aims are:

• Principal aim: to evaluate the efficacy and clinical performance of Crystal Peel, a salicylic-based peel, for the treatment of acne by lesions counting (front, 2 cheeks, the chin above the jaw line (excluding the nose)) using both visual observation and palpation.
• Secondary aims: pores and texture analysis, visual effect (Standardized anonymized photographs, investigator global assessment, patient global assessment, local and overall tolerance of the Crystal Peel, subject's self-evaluation and potential adverse events collection. The primary endpoint of the study will be an objective counting of the acne lesions performed on every visit.

Conditions

Acne Vulgaris

Keywords

acne; facial; crystal peel; salicylic acid; chemical peel

Outcome Measures

Primary Outcomes (1)

• Comparison of the Change From Baseline of Count Lesions on Each Visit to Evaluate the Efficacy and Clinical Performance of Crystal Peel for the Treatment of Acne.

  Lesion counting using both visual observation and palpation. Total lesions (front, 2 cheeks, the chin above the jaw line (excluding the nose)) will be defined as the sum of inflammatory lesions (papules, pustules), non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules).

  At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).

Secondary Outcomes (15)

• Acne Investigator Global Assessment (IGA) Score

  At Visit 5/Day 78.

• Acne Patient Global Assessment (PGA) Scale

  At Visit 5/Day 78.

• Local and Overall Tolerance of the Crystal Peel.

  At Visit 5/Day 78).

• Subject's Satisfaction Questionnaire

  At Visit 5/Day 78.

• Number of Adverse Events

  At each protocol visit (i.e: Visit 1/Day 0, Visit 2/Day 15, Visit 3/Day 36, Visit 4/Day 57 and Visit 5/Day 78).

Study Arms (1)

Crystal Peel

OTHER

2.5 ml of Crystal peel applied up to 3 coats and performed 3 times in the study (i.e: at Day 15, Day 36 and Day 57.

Device: Crystal Peel

Interventions

Crystal Peel DEVICE

3 applications performed by a dermatologist.

Crystal Peel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects
• Gender: female and/or male.
• Age: 18 - 45
• Phototype I to IV according Fitzpatrick scale.
• Healthy subject with normal physical examination results and a medical history compatible with the requirements of the study.
• A healthy male or female subject with a medical diagnosis of mild to moderate facial acne vulgaris defined by at least 6 (six) inflammatory lesions, 12 (twelve) non-inflammatory lesions and no more than 2 (two) nodules (the nose is excluded for lesion count purposes).
• Subject declares to avoid exposure to UV radiation (tanning booths, phototherapy and sun) on the face for at least three months prior to the selection visit and agrees to avoid it throughout the study.
• Subject agrees not to apply any cosmetic, medical or aesthetic treatments outside the study protocol on the face for the duration of the study.
• For female subjects:
• Female subject not in childbearing status (tubal ligation, hysterectomy, bilateral oophorectomy), or Female subjects of childbearing potential who, in the opinion of the investigator, are using a reliable method of contraception (pill or contraceptive patch, IUD, implant or vaginal ring,condoms) for at least one month prior to the screening visit. Subject willing to continue using contraception during the study and one month after the end of the study.

You may not qualify if:

• Pregnant or nursing woman or planning a pregnancy during the study.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment.
• Intensive exposure to sunlight or UV-rays within the previous 3 months and foreseen during the study.
• Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk.
• Subject having history of allergy or hypersensitivity to one of the components of the tested device.
• Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.
• Subjects on topical or oral treatments (such as Benzoyl Peroxide, Retinoic Acid, isotretinoin) that did not stop the treatment 30 days before their first peel (risk of over-peeling).
• Subjects with known salicylism or related medical indications.

Sponsors & Collaborators

• Dermosciences France: lead
• Eurofins: collaborator

Study Sites (1)

Eurofins Dermscan Poland

Gdansk, Poland

Location

MeSH Terms

Conditions

Acne Vulgaris; Facies

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sara Bayo Rodriguez
• Organization: Dermosciences France

clinicaltrials@dermaceutic.com

638966321

Study Officials

• Beata IMKO-WALCZUK, Dr

  Eurofins Dermscan Poland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: April 20, 2023
• Study Start: January 23, 2023
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)