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Completed

NCT Number: NCT02593383

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Dermatology, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 40 years old, female or male;
  • Class I-III of Acne vulgaris according to the International Modified PILLSBURY Classification;
  • Patients voluntarily take part in the study and sign the ICF.

Exclusion criteria

  • The subject is known to be allergic to adapalene, clindamycin hydrochloride, clindamycin, and / or any components of gel excipient;
  • Patients with secondary acne including occupational acne and corticosteroid-induced acne;
  • 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;
  • Subject has the history of regional enteritis, ulcerative colitis or antibiotic-associated colitis;
  • Patient has history of severe cardiac disease and hypertension;
  • Patient has severe liver and kidney diseases with AST/ALT more than twice upper limitation, or Cr, total cholesterol and triglycerides above normal range;
  • Patients with severe endocrine diseases, blood diseases, and neuropsychiatric disorders;
  • Patients are known to have severe immune dysfunction, or need long-term use of corticosteroids or immunosuppressive agents;
  • Pregnant or breastfeeding women, or unwilling to take effective contraceptive measures during the study;
  • Alcoholic patients or drug abusers;
  • Patient has used other acne drugs topically within 2 weeks before the study start;
  • Patient has been administered with victoria A acid, vitamins, and antibiotics within 4 weeks before the study start;
  • Patient has participated in other study within 3 months before the study start;
  • The subject is not fit to take part in this study in the judgment of the investigator.

Treatment and study plan

Adapalene + Clindamycin Hydrochloride

Drug

0.1% Adapalene + 1% Clindamycin Hydrochloride

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lee's Pharmaceutical Limited

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2015
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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