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Trial record 33 of 233 for:    acne AND Percent

A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03615768
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Combination Product: Adapalene-Clindamycin Combination Gel Drug: Adapalene Gel Drug: Clindamycin Gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1617 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Single-blind, Paralelle, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Moderate Acne Vulgaris
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Adapalene-Clindamycin Combination Gel Combination Product: Adapalene-Clindamycin Combination Gel
5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks

Active Comparator: Adapalene Gel Drug: Adapalene Gel
Differin 0.1% Gel, applied nightly for 12 weeks
Other Name: Differin

Active Comparator: Clindamycin Gel Drug: Clindamycin Gel
Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks
Other Name: Clindamycin




Primary Outcome Measures :
  1. Percentage Change From Baseline in Total Lesion Counts [ Time Frame: Week 12 ]
    Percent change from Baseline in total lesions counts in each treatment group at Week 12.

  2. Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percentage change from baseline in inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.

  2. Percentage change from baseline in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.

  3. Change from baseline in inflammatory lesion counts [ Time Frame: Week 12 ]
    Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.

  4. Change from baseline in non-inflammatory lesion counts [ Time Frame: Week 12 ]
    Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.

  5. Change from baseline in total lesion counts [ Time Frame: Week 12 ]
    Absolute change from baseline in total lesions counts in each treatment group at Week 12.

  6. Change from baseline in Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]
    Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.

  7. Treatment success rate [ Time Frame: Week 12 ]
    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.


Other Outcome Measures:
  1. Local Adverse Reactions [ Time Frame: Week 2, Week 4, Week 8 and Week 12 ]
    Local Adverse Reactions including erythema, scaling, stinging, burning and pruritus scored by severity



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 12-40 years old
  • Diagnosis of Grade II-III acne vulgaris with Pillsbury grading system
  • Provide written informed consent if the subject is aged 18 or older. Ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian.

Exclusion Criteria:

  • Known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution
  • Secondary Acne, such as occupational acne and steroid acne
  • Has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema
  • History of Crohn's disease, ulcerative colitis or antibiotic-associated colitis
  • History of serious heart disease or hypertension
  • Serious liver or kidney disease, AST or ALT more than twice the upper limit of normal, or Cr above normal
  • Serious endocrine, hematologic or psychiatric disease
  • Known immunocompromised conditions, or require long-term steroids or immunosuppressants
  • Females who are pregnant, lactating, or not willing to use effective contraception
  • Drug or alcohol abuse
  • Used any topical acne treatment within 2 weeks
  • Used any systemic retinoid, antibiotic or other acne treatment
  • Used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial
  • Patient who the investigator deemed to be unsuitable for any reason

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): NCT03615768


Contacts
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Contact: Yu Zhu +86-15996345850 zhuyu@leespharm.com

Locations
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China, Jiangsu
Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences Recruiting
Nanjing, Jiangsu, China, 210042
Contact: Yu Zhu       zhuyu@leespharm.com   
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited
Investigators
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Principal Investigator: Heng Gu, MD Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03615768     History of Changes
Other Study ID Numbers: ZK-ACG-201712
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
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