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evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treat group 1 | Experimental | Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride |
|
| Treatment group 2 | Experimental | Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride |
|
| Treatment group 3 | Experimental | Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride |
|
| Treatment group 4 | Experimental | Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride |
|
| Placebo group | Placebo Comparator | Placebo Group: Blank Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene + Clindamycin Hydrochloride | Drug | 0.1% Adapalene + 1% Clindamycin Hydrochloride |
| |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy endpoint | number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group; | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IGA classification change | The improvement of IGA (investigator general Assess)Classification at the treatment end (Day 85±3) in each group | 12 weeks |
| treatment success rate | The treatment success rate at the treatment end (Day 85±3) in each group; calculation methods:number of patients with IGA assessment improved to level 0 to level 1/ total number of patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heng GU, MD | Institute of Dermatology, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Dermatology, Chinese Academy of Medical Sciences | Nanjing | Jiangsu | 210042 | China |
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| Adapalene + Clindamycin Hydrochloride |
| Drug |
0.1% Adapalene + 2% Clindamycin Hydrochloride |
|
| Adapalene + Clindamycin Hydrochloride | Drug | 0.05% Adapalene + 0.5% Clindamycin Hydrochloride |
|
| Adapalene + Clindamycin Hydrochloride | Drug | 0.05% Adapalene + 1% Clindamycin Hydrochloride |
|
| Placebo | Drug |
|
| 12 weeks |
| PK | AUC | 12 weeks |
| PK | peak plasma concentration | 12 weeks |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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