Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02481-54 | Other Identifier | Agence National de Sécurité du médicament et des produits de santé |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salicylic acid & Epiduo 0.1%-2.5% Topical Gel | Experimental | Salicylic acid: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks. |
|
| Hydréane légère & Epiduo 0.1%-2.5% Topical Gel | Placebo Comparator | Hydréane légère: Once-a-day, on the morning, during 12 weeks. Epiduo gel: Once-a-day, on the evening (before bedtime) during 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiduo | Combination Product | 100 per arm Adapalene/ Benzoyl Peroxide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 0 (baseline) and Week 12 (final time point) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
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:
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)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INTERTEK | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28573779 | Result | 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. | |
| 29369333 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2018 |
Not provided
100 subjects per arm
Not provided
Not provided
double blind
| Salicylic Acid | Drug | Salicylic Acid |
|
| Hydréane légère | Other | moisturizer |
|
| Week 4 and Week 8 (intermediary times point) |
| 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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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:
The following scale will be used:
| Week 12 (final time point) |
| 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:
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. | Week 0 (baseline), Week 4 and Week 8 (intermediary times point) and Week 12 (final time point) |
| 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:
| Week 12 (final time point) |
| 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:
The following scale will be used:
| Week 12 (final time point) |
| 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. | Week 0 (baseline) and Week 12 (final time point) |
| 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 | From Week 0 (baseline) to Week 12 (final time point) |
| 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. |
| 27177989 | Result | 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. |
| 27514932 | Result | 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. |
| 26897386 | Result | 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. |
| Jan 25, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| D020156 | Salicylic Acid |
| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000068816 | Adapalene |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D010636 | Phenols |
Not provided
Not provided