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Acne VulgarisNCT05821296

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

A study testing Crystal Peel in people with Acne Vulgaris, run by Dermosciences France at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Acne Vulgaris
What is being tested?
Crystal Peel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePoland
Study dates
23 Jan 2023to 7 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Eurofins Dermscan Poland

    Gdansk

Other trials in Poland

About this study

Official title: Evaluation of the Efficacy and Tolerance of Crystal Peel (a Salicylic Acid Based Peel) in the Treatment of Acne

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.

Read the 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
Being tested
Crystal Peel
Keywords
acne, facial, crystal peel, salicylic acid, chemical peel
Medical subject headings
Acne Vulgaris, Facies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crystal PeelDevice

    3 applications performed by a dermatologist.

Study groups in NCT05821296
Study groupRoleWhat they receive
Crystal PeelOther2.5 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.
Receives: Device: Crystal Peel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)
  1. Acne Investigator Global Assessment (IGA) Score

    Investigator's global assessment of acne condition improvement at Day 78 (last protocol visit). The score range is -1 to 3, with higher scores denoting better outcomes, better acne condition improvement from baseline. Score ranges details: -1 (worse), 0 (no improvement), 1 (good improvement), 2 (very good improvement) on Day 78 (last protocol visit).

    Measured: At Visit 5/Day 78.

  2. Acne Patient Global Assessment (PGA) Scale

    Patient's global assessment of acne condition improvement at Day 78 (last protocol visit). The score range is -1 to 3, with higher scores denoting better outcomes, better acne condition improvement from baseline. Score ranges details: -1 (worse), 0 (no improvement), 1 (good improvement), 2 (very good improvement) on Day 78 (last protocol visit).

    Measured: At Visit 5/Day 78.

  3. Local and Overall Tolerance of the Crystal Peel.

    At the end of the study, the local tolerance on the skin of the product has been assessed during the clinical examination by the investigator by the "Local tolerance scale" (from 0 to 3, where higher scores mean better outcome) according to the following scores: 0= bad tolerance; 1= moderate tolerance; 2= good tolerance and 3= very good tolerance.

    Measured: At Visit 5/Day 78).

  4. Subject's Satisfaction Questionnaire

    Count and percentage of subjects who answered satisfactorily to the 17-item questionnaire that measured patients' satisfaction after use of Crystal Peel in treating acne at Day 78 (final protocol visit).

    Measured: At Visit 5/Day 78.

  5. Number of Adverse Events

    Collection of adverse events by the investigator. Please refer to Adverse Events tables for more details.

    Measured: 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).

  6. Comparison of Change From Baseline of Conspicuous Number of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.

    Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous number is defined as the number of distinct elements in the segmentation. A decrease of the conspicuous number of pores results in a decrease of the number of pores that are detected by the algorithm. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores.

    Measured: 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).

  7. Comparison of Change From Baseline of Conspicuous Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.

    Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous area is defined as the total number of pixels in the segmentation (total surface of detected pores). A decrease of the conspicuous area results in a decrease of the total surface occupied by detected pores. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores.

    Measured: 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).

  8. Comparison of Change From Baseline of Conspicuous Relative Area (Density) of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.

    Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm.The relative area is defined as the area of segmentation divided by total area of the region of interest. A decrease of conspicuous relative area results in a decrease of the detected pores conspicuous density. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores.

    Measured: 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).

  9. Comparison of Change From Baseline of Conspicuous Depth of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.

    Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous depth is defined as the difference of intensity between detected pores segmentation and surrounding segmentation. It is an average value over the whole region of interest. A decrease of conspicuous depth results in a decrease of detected pores visibility. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores.

    Measured: 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).

  10. Comparison of Change From Baseline of Average Area of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.

    Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The average area is defined as the area of segmentation divided by the number of distinct elements in the segmentation. It represents the average area of one detected pore. A decrease of the average area results in a decrease of the average size of detected pores or remaining detected pores if number decreases. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores.

    Measured: 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).

  11. Comparison of Change From Baseline of Conspicuous Volume of Detected Pores on Each Visit to Evaluate the Improvement of Pores Assessed by Colorface Device.

    Front face image with parallel polarization will be analyzed. A region of interest is defined on the cheek near the nose of each subject at baseline, it has the same size for all subjects and is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous volume is defined as the multiplication of conspicuous area and conspicuous depth. A decrease of conspicuous volume results in a decrease of detected pores visibility. There is an improvement of pores if and only if one of the following parameters is decreasing and the other ones are stable (no statistically significance) or decreasing: conspicuous number, conspicuous area, average area, conspicuous density, conspicuous depth and conspicuous volume of detected pores.

    Measured: 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).

  12. Comparison of Change From Baseline of Conspicuous Area of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.

    Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous total area is defined as the number of pixels in segmentation of detected line marks. A decrease of conspicuous area results in a decrease of the total size of cheek line marks. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit).

    Measured: 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).

  13. Comparison of Change From Baseline of Conspicuous Depth of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.

    Profiles images with parallel polarization will be analyzed by Colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The average conspicuous depth is defined as the difference of intensity between segmentation and surrounding segmentation. A decrease of conspicuous depth results in a decrease of cheek line marks visibility. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit).

    Measured: 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).

  14. Comparison of Change From Baseline of Conspicuous Length of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.

    Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous length is defined as the total number of pixels in the morphological skeleton of segmentation. The morphological skeleton is defined as the central element of unit width of segmentation of detected line marks. A decrease of conspicuous length results in a decrease of the cumulated length of detected cheek line marks. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit).

    Measured: 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).

  15. Comparison of Change From Baseline of Conspicuous Volume of Line Marks on Each Visit to Evaluate the Improvement of Line Marks Assessed by Colorface Device.

    Profiles images with parallel polarization will be analyzed by colorface device. A region of interest is delimited on the cheek of each subject at baseline and it is automatically repositioned at other timepoints for the same subject, thanks to a spatial registration algorithm. The conspicuous volume is defined as the multiplication of conspicuous area and conspicuous depth. A decrease of conspicuous volume results in a decrease of cheek line marks visibility. There is an improvement of line marks if and only if one of the following parameters is decreasing and others ones are stable (no statistically significance) or decreasing: conspicuous area (unit=number of pixels), conspicuous length (unit=number of pixels), conspicuous depth (unit=arbitrary unit) and conspicuous volume of line marks (unit=arbitrary unit).

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start23 Jan 2023
  3. Primary completion7 Jun 2023
  4. Study completion7 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05821296
Sponsor's protocol ID
22E2387
Status last verified
Oct 2024
First submitted
3 Feb 2023
Last updated
15 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Crystal Peel in people with Acne Vulgaris, run by Dermosciences France at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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