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The change of bacterial microbiome after using La Roche-Posay Effaclar Duo plus compared to retinoic acid 0.025% cream and benzoyl peroxide 2.5% gel in mild acne vulgaris

Phase 4
Completed
Conditions
Patients with mild acne vulgaris (defined by IGA 1 and 2)
Acne vulgaris, skin microbiome, La Roche-Posay Effaclar duo plus, VAA cream, Benzoyl peroxide
Registration Number
TCTR20210531009
Lead Sponsor
'Oreal Thailand
Brief Summary

Topical application of DC, VAA, or BP can significantly and differently modulate the skin microbiota in AV participants.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
45
Inclusion Criteria

1.Men or women with 18-45 years old at the time of screening
2.Presence of minimum of 10 comedones and maximum of 5 inflammatory acne on the face
3.Mild acne vulgaris defined as IGA 1 (Almost clear; rare noninflammatory lesions with more than one small inflammatory lesion) to IGA 2 (Mild severity; some inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
4.Subjects who are willing to use nonantibacterial bar soap for facial cleansing throughout the study
5.Subjects who are informed in detail about the research study and express their interests in participation.
6.Subjects must be able to comply with study protocol

Exclusion Criteria

1.History of systemic or topical antibiotic use within 1 month prior to the baseline study visit
2.Dermatologic procedural treatments within previous 6 months before study enrollment
3.Systemic acne treatment within 4 weeks before study enrollment.
4.Topical acne treatment within 2 weeks before study enrollment.
5.Female subjects who have significant signs of hyperandrogenism or history of irregular menstrual cycles
6.Female subjects who are currently in pregnancy or breastfeeding

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Alteration in facial microbiome profiles(changes in proliferation and diversity of facial microbiota) in each arm of treatment baseline, 1st and 3rd month 16s rRNA sequencing from facial swabs,Reduction on acne lesion count baseline, 1st month and 3rd month Acne lesion count was performed by counting of each different types of acne (closed comedones, open comedones, inflammatory papules, pustules) on each designated area of the face
Secondary Outcome Measures
NameTimeMethod
Adverse effects 1st and 3rd month Adverse effects such as active dermatitis, redness, edema, dryness will be graded by 4-point grading scores,Subject's satisfaction 3rd month Satisfaction is evaluated by VAS score
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