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

September 23, 2019 updated by: Lee's Pharmaceutical Limited

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210042
        • Institute of Dermatology, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treat group 1
Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride
Experimental: Treatment group 2
Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride
Experimental: Treatment group 3
Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride
Experimental: Treatment group 4
Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 1% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.1% Adapalene + 2% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Drug: Adapalene + Clindamycin Hydrochloride
0.05% Adapalene + 1% Clindamycin Hydrochloride
Placebo Comparator: Placebo group
Placebo Group: Blank Gel
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
efficacy endpoint
Time Frame: 12 weeks
number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
12 weeks
PK
Time Frame: 12 weeks
AUC
12 weeks
PK
Time Frame: 12 weeks
peak plasma concentration
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lee's Pharmaceutical Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heng GU, MD, Institute of Dermatology, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • zhaoke-2015-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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