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Trial record 50 of 231 for:    clindamycin

Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne

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ClinicalTrials.gov Identifier: NCT02593383
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief Summary:
evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.

Condition or disease Intervention/treatment Phase
Acne Drug: Adapalene + Clindamycin Hydrochloride Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo Control, Multicenter, Randomized, Double Blind, Multi-formula Groups, and Parallel Phase Ⅰb+Ⅱa Study Evaluating the Safety and Efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017


Arm Intervention/treatment
Experimental: Treat group 1
Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride

Experimental: Treatment group 2
Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride

Experimental: Treatment group 3
Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride

Experimental: Treatment group 4
Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride

Placebo Comparator: Placebo group
Placebo Group: Blank Gel
Drug: Placebo



Primary Outcome Measures :
  1. efficacy endpoint [ Time Frame: 12 weeks ]
    number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;


Secondary Outcome Measures :
  1. IGA classification change [ Time Frame: 12 weeks ]
    The improvement of IGA (investigator general Assess)Classification at the treatment end (Day 85±3) in each group

  2. treatment success rate [ Time Frame: 12 weeks ]
    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

  3. PK [ Time Frame: 12 weeks ]
    AUC

  4. PK [ Time Frame: 12 weeks ]
    peak plasma concentration



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age from 18 to 40 years old, female or male;
  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:

  1. The subject is known to be allergic to adapalene, clindamycin hydrochloride, clindamycin, and / or any components of gel excipient;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593383


Locations
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China, Jiangsu
Institute of Dermatology, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China, 210042
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
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Principal Investigator: Heng GU, MD Institute of Dermatology, Chinese Academy of Medical Sciences

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT02593383     History of Changes
Other Study ID Numbers: zhaoke-2015-02
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by Lee's Pharmaceutical Limited:
safety
efficacy
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents