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

NCT ID: NCT05821296

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2023-06-07

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.

Detailed Description

Total lesions will be defined as the sum of inflammatory lesions (papules and pustules), non-inflammatory lesions (whiteheads and blackheads) and other acne lesions (nodules).

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Crystal Peel

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.

Group Type: OTHER

Crystal Peel

Intervention Type: DEVICE

3 applications performed by a dermatologist.

Interventions

Crystal Peel

3 applications performed by a dermatologist.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy subjects

2. Gender: female and/or male.

3. Age: 18 - 45

4. Phototype I to IV according Fitzpatrick scale.

5. Healthy subject with normal physical examination results and a medical history compatible with the requirements of the study.

6. 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).

7. 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.

8. Subject agrees not to apply any cosmetic, medical or aesthetic treatments outside the study protocol on the face for the duration of the study.

9. 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.

Exclusion Criteria

1. Pregnant or nursing woman or planning a pregnancy during the study.

2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.

3. Subject in a social or sanitary establishment.

4. Subject participating to another clinical research or being in an exclusion period for a previous study.

5. Intensive exposure to sunlight or UV-rays within the previous 3 months and foreseen during the study.

6. 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.

7. Subject having history of allergy or hypersensitivity to one of the components of the tested device.

8. Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.

9. 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).

10. Subjects with known salicylism or related medical indications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins

INDUSTRY

Sponsor Role: collaborator

Dermosciences France

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beata IMKO-WALCZUK, Dr

Role: PRINCIPAL_INVESTIGATOR

Eurofins Dermscan Poland

Locations

Eurofins Dermscan Poland

Gdansk, , Poland

Countries

Poland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22E2387

Identifier Type: -

Identifier Source: org_study_id