Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05216289 |
| Other study ID # |
Probiac |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2018 |
| Est. completion date |
April 1, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Federal University of São Paulo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective: Clinical trial carried out to evaluate the superiority of efficacy of a treatment
regimen with an oral probiotic associated with a fixed combination of 0.1% adapalene and 2.5%
benzoyl peroxide compared to an oral placebo with the same topical treatment in patients with
mild to moderate acne.
Patients and Methods: This was a randomized, double-blind, placebo-controlled study conducted
with 212 patients aged from 12 to 35 years; 107 in the test treatment arm and 105 in the
comparator arm. The study was divided into two phases of 90 days each, totaling 180 days. In
the first phase, patients received treatment with 2.5% benzoyl peroxide and 0.1% adapalene
associated with a probiotic (IT), or 2.5% benzoyl peroxide and 0.1% adapalene associated with
placebo (CT). In the second phase (90 days), patients received only oral treatment with a
probiotic or placebo. Efficacy criteria were: reduction of the Investigator Global Assessment
(IGA) scale to 0 or 1, and reduced lesion count.
Description:
Four hundred participants of both genders aged between 12 and 35 years, diagnosed with grade
II and III acne, mixed or oily skin and phototype between I and IV, according to the
Fitzpatrick scale, were recruited. Pregnant or lactating women, as well as those intending to
become pregnant during the study period were excluded, in addition to patients who received
treatment with corticosteroids and antimicrobials within 30 days prior to selection and those
who were treated with immunosuppressants within 90 days prior to selection.
The study was conducted in Osasco-SP, Brazil, at Medcin Instituto da Pele Ltda., in the
period from April 18th, 2018 to April 7th, 2021. The study protocol was approved by the
Research Ethics Committee at Universidade São Francisco-SP on December 14, 2018. CAAE:
03728318.5.0000.5514 Opinion Number: 3,083,043. All participants signed the Informed Consent
Form (ICF) and the research was conducted in accordance with Good Clinical Practice and the
1996 Declaration of Helsinki.
Study Design and Treatment This was a randomized, double-blind, 2-arm, placebo-controlled
study conducted to assess the superiority of treatment with the oral probiotic composed of
Lactobacillus acidophilus, Bifidobacterium lactis, vitamins and minerals - Exímia Probiac®
(EP), in combination with 2.5% benzoyl peroxide plus 0.1% adapalene (PBA) for topical use,
compared to PBA in combination with placebo in improving the clinical condition of acne
patients.
Eligible patients were randomized into 2 groups to receive one of the treatments. Both
topical and oral treatments were administered once a day. All patients received a bottle of
SPF50 sunscreen on the first visit and were instructed to use it daily. All study samples
were supplied by the company Farmoquímica S/A.
The study was divided into two phases of 90 days each, totaling 180 days of study. Patients
were evaluated at the baseline visit (D0) and every 30 days thereafter, totaling 7 visits. At
Day 0 visit, patients received the randomized treatment and guidelines for use. In the first
phase (90 days), patients received treatment with PBA plus PE (Investigational Treatment -
IT) or PE plus placebo (Comparator Treatment - CT). In the second phase (90 days), patients
received only oral treatment with PE or placebo.
At each visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180), patients were
clinically evaluated and the results in relation to the Investigator Global Assessment (IGA)
scale were recorded.
Efficacy criteria
The primary variables of the study were the reduction in the IGA scale score to grade 1 or 0,
as well as the reduction in the total number of inflammatory and non-inflammatory lesions in
the facial region. For IGA quantification, scores were assigned according to an established
scale:
0 = Clean skin: Residual hyperpigmentation and erythema may be present;
1. = Almost clean: Some scattered comedones and some small papules;
2. = Mild: Less than half of the face is affected, some comedones and some papules and
pustules;
3. = Moderate: More than half of the face is affected, some comedones and some papules and
pustules. A lump may be present;
4. = Severe: Whole face severely affected by comedones, numerous papules and pustules, and
some nodules and cysts.
Statistical analysis
The results obtained from clinical, instrumental and subjective evaluations were compared
between experimental time points and later between treatments. The hypothesis tests used in
the study had a significance level of 95% and the statistical power of these tests was above
80%. Descriptive analyses of the study variables were performed using frequency tables and
descriptive statistics. The percentage of participants with a reduction in the total number
of inflammatory and non-inflammatory lesions, the percentage of participants with regression
of the IGA scale score to no lesions (score zero) or almost no lesions (score one) were
evaluated using the Z test for comparison of two proportions. The results were considered
statistically significant at a significance level of 5% (p-value ≤0.05). The significance
level was controlled by rejecting the null hypotheses if the p-value was less than or equal
to 5%.
