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Three hundred healthy women between 25 and 35 years with mild acne, of any phototype, with no topical acne treatment within the two previous weeks, no oral acne treatment within the four previous weeks for antibiotics or 6 months for isotretinoin and no other face dermatoses were recruited.
All women who provided written consent and met the inclusion criteria were randomized at each study site in a 1 : 1 : 1 way to receive for 90 days:.
Table 1 summarizes treatment regimens. Investigators were not aware of the regimens to which subjects were randomized. Products were provided in neutral cardboard boxes with an instruction leaflet on how to apply the products. The primary evaluation endpoint was the mean acne lesion count after 90 days.
Clinical evaluations at Day 0, 45 and 90 included the count of papules, pustules, nodules and inflammatory cysts, as well as of open and closed comedones. Local tolerance was assessed at Day 45 and At Day 90, the investigators and subjects rated the skin care regimens globally.
The Mann—Whitney test was used to compare the distribution of lipid variables between groups; the Wilcoxon test was used for the intragroup comparison.
At Day 0, demographic median age 29 years 24—36 in Group A, 30 years 24—36 in groups B and C , clinical and cutaneous lipid characteristics were similar for all three groups. Mean acne lesion count at Day 0 and Day Differences were statistically significant at Day 90 from Day 0 for all treatment groups. Mean papules and pustules counts at D0: Mean papules and pustules counts at D 3. Mean of the deltas D90 vs. Group A Fig. Skin aspect, discomfort and stinging at Day 0 and Day Differences between Group B and C vs.
Group A at Day 90 were significant for all items. No subject withdrew from the study for any tolerance or safety issues and no adverse events were reported. Group A and for Group B vs. Group C. A total of 70 complete skin lipid profiles 23 from Group A, 23 from Group B and 24 from Group C were available for quantitative skin lipid assessment.
At Day 90, the lipid profile had significantly improved for all subjects. Detailed mean results at Day 0 and 90 are provided in Fig. Modifications of lipid compounds at Day 90 compared to Day 0. SQOOH , oxidized squalene. Interestingly, the improvement was significantly higher with regimens comprising the test care, not only when the fixed combination was applied daily Group C but also when this combination was applied every other evening Group B. This could be related to the fact that the test care decreases the alterations of barrier that fixed combination induces and help restore microbiote, lipidic film and stratum corneum.
Squalene and waxes are characteristic compounds of sebaceous glands lipids while sterols are components of the epidermal lipids. Moreover, the decreased quantity of waxes and glycerides may indicate a better moisturized and protected skin via a higher filmogen activity while the observed decrease in oxidized squalene suggests a decreased P.
Results of this study show that the skin barrier function might have improved after 90 days of daily application of the test care adjunctively to the fixed combination and a standard emollient. This improvement may be potentially due to the fact that the test care improved the free fatty acid profile while it rebalanced the profile of reserve forms playing a role in the improved skin discomfort.
No such improvement was observed with the standard emollient alone. It may enable the use of the adapalene and benzoyl peroxide combination once every other day. Conflicts of interest None declared. Funding sources This study was funded by Laboratoires Vichy, France. Journal of the European Academy of Dermatology and Venereology.
J Eur Acad Dermatol Venereol. Published online Jul 7. Bouloc , 1 E. Moga , 4 B. Chadoutaud , 5 and B. Author information Article notes Copyright and License information Disclaimer. Bouloc, Email: moc. Corresponding author. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government.
Read our disclaimer for details. Results First Posted : March 16, Last Update Posted : August 23, Study Description. Detailed Description:.
Drug Information available for: Benzoyl peroxide Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate Adapalene Benzoyl peroxide, clindamycin drug combination. FDA Resources. Arms and Interventions. Outcome Measures.
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
Eligibility Criteria. Inclusion Criteria: Subjects with a minimum of 20 inflammatory lesions on the face; Subjects with a minimum of 15 and a maximum of non-inflammatory lesions open and closed comedones on the face, excluding the nose; Subject has a Global Severity Assessment Exclusion Criteria: 1.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information.
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