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| Name | Class |
|---|---|
| Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. | INDUSTRY |
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This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene-Clindamycin Combination Gel | Experimental |
| |
| Adapalene Gel | Active Comparator |
| |
| Clindamycin Gel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene-Clindamycin Combination Gel | Combination Product | 5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Total Lesion Counts | Percent change from Baseline in total lesions counts in each treatment group at Week 12. | Week 12 |
| Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in inflammatory lesion counts | Percent change from baseline in inflammatory lesions count in each treatment group at Week 12. | Week 12 |
| Percentage change from baseline in non-inflammatory lesion counts |
| Measure | Description | Time Frame |
|---|---|---|
| Local Adverse Reactions | Local Adverse Reactions including erythema, scaling, stinging, burning and pruritus scored by severity | Week 2, Week 4, Week 8 and Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heng Gu, MD | Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences | Nanjing | Jiangsu | 210042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39487326 | Derived | Luan C, Yang WL, Yin JW, Deng LH, Chen B, Liu HW, Zhang SM, Han J, Liu ZJ, Dai XR, Yin QJ, Yu XH, Chen K, Gu H, Li BXY. Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial. Dermatol Ther (Heidelb). 2024 Nov;14(11):3097-3112. doi: 10.1007/s13555-024-01286-x. Epub 2024 Nov 1. |
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| 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 |
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| Adapalene Gel | Drug | Differin 0.1% Gel, applied nightly for 12 weeks |
|
|
| Clindamycin Gel | Drug | Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks |
|
|
Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.
| Week 12 |
| Change from baseline in inflammatory lesion counts | Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12. | Week 12 |
| Change from baseline in non-inflammatory lesion counts | Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12. | Week 12 |
| Change from baseline in total lesion counts | Absolute change from baseline in total lesions counts in each treatment group at Week 12. | Week 12 |
| Change from baseline in Investigator's Global Assessment (IGA) | Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12. | Week 12 |
| Treatment success rate | The proportion of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)"; if IGA score at baseline is 2, success is only achieved if IGA score is 0 at Week 12. | Week 12 |
| 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 |