AzTrials
AzTrials

AcnePhase 4NCT03832647

Anti-acne Efficacy of a Dermo-cosmetic Product Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer in Male and Female Subjects Presenting With Mild to Moderate Acne

A Phase 4 study testing Epiduo, Salicylic Acid and Hydréane légère in people with Acne, run by Vichy Laboratoires at 1 site in France.

Completed

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

Official record
Search all trials

Trial summary

Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment Multi centre… Read more about this study

Who is it for?
Ages 16 to 35 years
Conditions the study is for
Acne
What is being tested?
Epiduo, Salicylic Acid and Hydréane légère
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteFrance
Study dates
18 Feb 2019to 17 Feb 2020
Phase
Phase 4
Are there results?
None posted in the registry

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 16 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Male and/or female subjects aged 16 to 35 years
  • Subjects presenting with mild to moderate acne (stage 2 or stage 3 with at least 12 inflammatory lesions on face according to the Global Acne Evaluation)
  • Female subjects of child-bearing potential who:
  • use the same reliable hormonal contraceptive method (oral contraceptive, implant, intra-uterine device, patch, cervical cap, vaginal ring and injection) for at least 3 months prior to study inclusion and throughout the study or
  • use a reliable non-hormonal contraceptive method (copper intra-uterine device, condoms, diaphragm, cervical cap and spermicide) for at least 1 month prior to study inclusion and throughout the study or
  • have no sexual intercourse and agreeing not to have any throughout the study or
Show all 10Show fewer
  • are surgically sterile (oophorectomy, hysterectomy or tubal ligation),
  • Subjects and/or all legal representatives (for minor subjects) who have given written informed consent
  • Subjects who are willing to comply with the study requirements
  • Subjects with Social Security (health insurance) coverage (according to the French requirements)

Who cannot join

  • Subjects with any systemic disorder or face dermatoses other than acne that would in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, or psoriasis)
  • Subjects with a condition or receiving a medication and/or with a history of medical/surgical events which, in the opinion of the Investigator, could compromise the safety of the subject or affect the outcome of the study
  • Subjects with a history of skin cancer
  • Female subjects who are pregnant (positive urine pregnancy test) or lactating or who are planning to become pregnant during the study
  • Subjects who have started, stopped or changed of hormonal treatment (contraception, thyroid …) in the 3 months prior the study inclusion
  • Subjects with hypersensitivity to the active substances of Epiduo (Adapalene and/or benzoyl peroxide) or to one of its excipients
Show all 20Show fewer
  • Subjects who are sensitive to peroxides (oxygenated water)
  • Subjects who have received isotretinoin treatment in the 6 months prior to study inclusion
  • Subjects who have been exposed to excessive UV light (natural or artificial) in the 1 month prior to the study inclusion or having planned excessive UV light exposure during the study (e.g. ski holidays, holidays in the tropics…)
  • Subjects who have used systemic drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 4 weeks prior to study inclusion
  • Subjects who have used topical drugs for more than 3 consecutive days related to antibiotics, anti-inflammatory, corticoids, anti-acneic in the 2 weeks prior to study inclusion
  • Subjects who have used scrub, anti-seborrheic topical cosmetic products and/or who have applied self-tanning products on face in the 1 week prior the study inclusion
  • Subjects who have applied cosmetic products for more than 5 consecutive days with alpha hydroxyl-acids, vitamin C, hyaluronic acids in the 1 week prior the study inclusion
  • Subjects having washed the face and/or the hair the day of the study inclusion (only water is accepted the morning of the study inclusion)
  • Subjects having applied any topical products on face (including make-up) the day of the study inclusion
  • Subjects who have planned a major surgery during the study requiring hospitalization under general anesthesia and the use of systemic or topical drugs (e.g. antibiotics, anti-inflammatory) for more than 1 week
  • Subjects who declare to be deprived of their freedom by administrative or legal decision or who are under guardianship
  • Subjects who cannot be contacted by telephone in case of emergency
  • Subjects belonging to the staff of the study centre
  • Subjects in an exclusion period or participating in another biomedical research study

Trial locations and contacts

1 site in 1 country.

France1 site

  • INTERTEK

    Paris, 75013

Other trials in France

About this study

Official title: Multicentric, Parallel, Randomized, Double Blind Study Under Dermatological Control to Evaluate the Anti-acne Efficacy of a Dermo-cosmetic Product (Fla 688977 33) Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer (Hydréane légère, Cosmétique Active International) During a 12-week Application Period in Male and Female Subjects Presenting With Mild to Moderate Acne

Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment

Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm), Intra-subject \& inter subject comparisons

Conditions
Acne
Being tested
Epiduo, Salicylic Acid, Hydréane légère
Medical subject headings
Acne Vulgaris

What participants receive

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

  • EpiduoCombination product

    100 per arm Adapalene/ Benzoyl Peroxide

  • Salicylic AcidDrug

    Salicylic Acid

  • Hydréane légèreOther

    moisturizer

Study groups in NCT03832647
Study groupRoleWhat they receive
Salicylic acid & Epiduo 0.1%-2.5% Topical GelExperimentalSalicylic acid: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
Receives: Combination Product: Epiduo; Drug: Salicylic Acid
Hydréane légère & Epiduo 0.1%-2.5% Topical GelPlacebo comparatorHydréane légère: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks.
Receives: Combination Product: Epiduo; Other: Hydréane légère

What is being measured

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

  1. Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions)

    Change in the number of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) on face after a 12-week application period At Week 0 (before any application) and Week 12 (after a 12-week application period), a counting of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) will be performed by a Dermatologist.

    The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).

    Measured: Week 0 (baseline) and Week 12 (final time point)

Secondary outcomes (22)

  1. Evaluation of the anti-acne efficacy 2 (number of the retentional and inflammatory lesions)

    Change in the number of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) on face after 4 and 8-week application period At Week 4 (after a 4-week application) and Week 8 (after a 8-week application period), a counting of the retentional (open \& closed comedones) and inflammatory lesions (papulae, pustulae \& nodules (if applicable)) will be performed by a Dermatologist.

    The counting will be broken down on several parts of the face (forehead, left and right cheeks and chin).

    Measured: Week 4 and Week 8 (intermediary times point)

  2. Change in the acne stage on face according to the Global Acne Evaluation scale after 4, 8 and 12-week application period

    At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), determination of the acne stage will be performed by the Dermatologist according to the Global Acne Evaluation scale (score min:0 to score max:5). More the score decreased, more the treatment is efficient.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  3. Change in the residual marks visibility after 4, 8 and 12-week application period

    At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the residual marks visibility of acne (hyperpigmentation) will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:numerous). More the score decreased, more the treatment is efficient.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  4. Change in the pores visibility after 4, 8 and 12-week application period

    At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the pores visibility will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:numerous). More the score decreased, more the treatment is efficient.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  5. Change in the skin shininess after 4, 8 and 12-week application period

    At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), the skin shininess will be assessed under the same conditions by the Dermatologist using the scale below which include 10 grades (0: absence to 9:high). More the score decreased, more the treatment is efficient.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  6. Change in skin greasiness after 4, 8 and 12-week application period

    At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.

    The CL measurements (quantity of sebum (casual level)) will be taken using a SEBUMETER®.

    The unit is in µg sebum/cm² of the skin. Only one measurement per subject will be taken in the middle of the forehead. More the value decreased, less the skin is greasy.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  7. Change in skin moisturizing after 4, 8 and 12-week application period

    At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.

    The measurements will be taken using a CM 825 PC CORNEOMETER®. The hydratation values are expressed in arbitrary units ranging from approximately 0 to 120.

    Three measurements per subject will be taken on the right cheekbone. More the value increased, more the skin is moisturize.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  8. Change in skin ph after 4, 8 and 12-week application period

    At Week 0, Week 4, Week 8 and Week 12, instrumental measurements will be performed by a technician/a nurse.

    The measurements will be taken using a SKIN PH METER 900®. The result will be expressed in pH units. Only one measurement per subject will be taken on the left cheek, near to the side of the nose. More the value decreased, more the ph is acid.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  9. Total number of hair follicles per cube at a mean depth of 38 µm after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  10. Diameter of the infundibulum in µm after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  11. Aspect of the border (thickness) (number and percentage) after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  12. Onion like appearence (number and percentage) after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  13. Presence of amorphous material into the infundibulum (number and percentage) after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  14. Signs of inflammation (number and percentage) after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  15. Vascularization (number and percentage) after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  16. Presence of Demodex mites (number and percentage) after a 12-week application period

    At Week 0 and Week 12, instrumental measurements will be performed by investigator at CHU Nantes.

    Confocal images are obtained by analyzing the reflection of a diode laser in the skin. The lens will be directly applied onto the selected skin area (on 3 nonlesional skin area: forehead, right temple and right mandibular).

    Confocal images will be analyzed by two confocal microscopy experts.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  17. Analysis of the efficacy on the skin quality using a questionnaire

    Subjects will complete an efficacy questionnaire at the last visit (after a 12-week application period of the Investigational Product (cosmetic product \& drug)).

    The following items will be evaluated by the subjects:

    1. Imperfections are less visible
    2. The skin is cleansed/purified
    3. The complexion is homogeneous / uniform
    4. The skin is comfortable
    5. The skin is like hydrated
    6. The skin is smoother
    7. The skin is softer
    8. The skin is suppler
    9. The skin is less brilliant
    10. The skin is matified
    11. Excess sebum is reduced
    12. The skin has a matte touch
    13. The pores of the skin are tightened
    14. Redness of the skin are reduced
    15. The skin texture is refined
    16. The marks of the skin are less visible

    The following scale will be used:

    • Agree ("D'accord")
    • Somewhat agree ("Plutôt d'accord")
    • Neither agree, nor disagree ("Ni d'accord ni pas d'accord")
    • Somewhat disagree ("Plutôt pas d'accord")
    • Disagree ("Pas d'accord")

    Measured: Week 12 (final time point)

  18. Analysis of the local tolerance using clinical assessments

    At Week 0 (before any application), Week 4 (after a 4-week application period), Week 8 (after an 8-week application period) and Week 12 (after a 12-week application period), a clinical assessment of the face skin condition will be performed by the Dermatologist:

    • Physical signs: erythema, dryness and scaling
    • Functional signs*: tightness, prickling, itching, burning sensation and others

    The following scale will be used:

    Rating 0: none ("absence") Rating 1: slight ("léger") Rating 2: moderate ("modéré") Rating 3: severe ("sévère")

    • During the study, the subjects will have to record any skin discomfort, intensity (slight, moderate or severe) and duration in their daily log. Functional signs will be assessed by the Dermatologist from a review of the daily log and interrogatory of the subject.

    In addition, at W12 (after a 12-week application period), the Dermatologist and the subject.

    Measured: Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point)

  19. Products overall tolerance appreciation by the Dermatologist and the subject

    In addition, at Week 12 (after a 12-week application period), the Dermatologist and the subject will state about the overall tolerance of the IP (cosmetic product \& drug) based on rating scale:

    • Excellent tolerance
    • Good tolerance
    • Medium tolerance
    • Poor tolerance

    Measured: Week 12 (final time point)

  20. Analysis of the cosmetic acceptability using a questionnaire

    Subjects will complete a cosmetic acceptability questionnaire concerning the cosmetic product at the last visit.

    The following items will be evaluated by the subjects:

    1. The product is easy to spread
    2. The product is easy to apply
    3. The product penetrates quickly
    4. The color of the product is pleasant
    5. The scent of the product is pleasant
    6. The aspect of the product is pleasant
    7. The texture of the product is pleasant
    8. The texture is comfortable
    9. The product doesn't leave the skin sticky
    10. The product doesn't leave a greasy film on the skin
    11. The product leaves a silky effect
    12. The product does not go noodles

    The following scale will be used:

    • Agree ("D'accord")
    • Somewhat agree ("Plutôt d'accord")
    • Neither agree, nor disagree ("Ni d'accord ni pas d'accord")
    • Somewhat disagree ("Plutôt pas d'accord")
    • Disagree ("Pas d'accord")

    Measured: Week 12 (final time point)

  21. Evaluation of the skin microbiota using sampling (if applicable)

    At Week 0 and at Week 12, microbiota sampling will be performed by the same sampler (technician/nurse).

    Skin microbiota sample will be collected on one test site of 4 cm2 on the middle of the left cheek and using aseptic techniques under sterile airflow generated by a portable hood.

    According to the results of the primary variable, the Sponsor will decide to go ahead with the microbiota analysis which will be done by INRA Transfert.

    DNA will be extracted from the swabs. PCR amplification will be performed for each DNA sample. DNA will be PCR amplified. Cleaned pools will be sequenced on the Illumina MiSeq platform.

    Sequences will be then de-replicated and a database containing one sequence for each operational taxonomic unit will be generated.

    Interpretation of these results will be done by Mercurialis.

    Measured: Week 0 (baseline) and Week 12 (final time point)

  22. Analysis of the number of subject with adverse event related to the study product

    Adverse Events will be collected during all the study from Week 0 to Week 12

    Measured: From Week 0 (baseline) to Week 12 (final time point)

Timeline

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

  1. First posted6 Feb 2019
  2. Study start18 Feb 2019
  3. Primary completion17 Feb 2020
  4. Study completion17 Feb 2020

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
100 subjects per arm
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03832647
Sponsor's protocol ID
VCA 18-01
Other IDs
2018-A02481-54
Status last verified
Oct 2021
First submitted
25 Jan 2019
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bouloc A, Roo E, Imko-Walczuk B, Moga A, Chadoutaud B, Dreno B. A skincare combined with combination of adapalene and benzoyl peroxide provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne. J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1727-1731. doi: 10.1111/jdv.14379. Epub 2017 Jul 7.

    PubMed 28573779

  • Muguet Guenot L, Vourc'h Jourdain M, Saint-Jean M, Corvec S, Gaultier A, Khammari A, Le Moigne M, Boisrobert A, Paugam C, Dreno B. Confocal microscopy in adult women with acne. Int J Dermatol. 2018 Mar;57(3):278-283. doi: 10.1111/ijd.13910. Epub 2018 Jan 25.

    PubMed 29369333

  • Gollnick HP, Bettoli V, Lambert J, Araviiskaia E, Binic I, Dessinioti C, Galadari I, Ganceviciene R, Ilter N, Kaegi M, Kemeny L, Lopez-Estebaranz JL, Massa A, Oprica C, Sinclair W, Szepietowski JC, Dreno B. A consensus-based practical and daily guide for the treatment of acne patients. J Eur Acad Dermatol Venereol. 2016 Sep;30(9):1480-90. doi: 10.1111/jdv.13675. Epub 2016 May 14.

    PubMed 27177989

  • Nast A, Dreno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, Finlay AY, Haedersdal M, Lambert J, Layton A, Lomholt HB, Lopez-Estebaranz JL, Ochsendorf F, Oprica C, Rosumeck S, Simonart T, Werner RN, Gollnick H. European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1261-8. doi: 10.1111/jdv.13776. No abstract available.

    PubMed 27514932

  • Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17.

    PubMed 26897386

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epiduo, Salicylic Acid and Hydréane légère in people with Acne, run by Vichy Laboratoires at 1 site in France.

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 20 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 18 Oct 2021. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluation of the anti-acne efficacy 1 (number of the retentional and inflammatory lesions) (time frame: Week 0 (baseline) and Week 12 (final time point)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03832647, which also lists 5 linked publications.

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 18 Oct 2021.

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