Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne
NCT ID: NCT02593383
Last Updated: 2019-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
245 participants
INTERVENTIONAL
2015-03-01
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treat group 1
Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
Treatment group 2
Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride
Treatment group 3
Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Treatment group 4
Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride
Placebo group
Placebo Group: Blank Gel
Placebo
Interventions
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Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Class I-III of Acne vulgaris according to the International Modified PILLSBURY Classification;
3. Patients voluntarily take part in the study and sign the ICF.
Exclusion Criteria
2. Patients with secondary acne including occupational acne and corticosteroid-induced acne;
3. The affected skin has other concomitant lesion (such as solar dermatitis, psoriasis, seborrheic dermatitis, eczema and extremely severe acne) which may impact the efficacy evaluation;
4. Subject has the history of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
5. Patient has history of severe cardiac disease and hypertension;
6. Patient has severe liver and kidney diseases with AST/ALT more than twice upper limitation, or Cr, total cholesterol and triglycerides above normal range;
7. Patients with severe endocrine diseases, blood diseases, and neuropsychiatric disorders;
8. Patients are known to have severe immune dysfunction, or need long-term use of corticosteroids or immunosuppressive agents;
9. Pregnant or breastfeeding women, or unwilling to take effective contraceptive measures during the study;
10. Alcoholic patients or drug abusers;
11. Patient has used other acne drugs topically within 2 weeks before the study start;
12. Patient has been administered with victoria A acid, vitamins, and antibiotics within 4 weeks before the study start;
13. Patient has participated in other study within 3 months before the study start;
14. The subject is not fit to take part in this study in the judgment of the investigator.
18 Years
40 Years
ALL
No
Sponsors
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Lee's Pharmaceutical Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Heng GU, MD
Role: PRINCIPAL_INVESTIGATOR
Institute of Dermatology, Chinese Academy of Medical Sciences
Locations
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Institute of Dermatology, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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zhaoke-2015-02
Identifier Type: -
Identifier Source: org_study_id
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