NCT02593383

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

2.4 years

First QC Date

July 16, 2015

Last Update Submit

September 23, 2019

Conditions

Acne

Keywords

safetyefficacy

Outcome Measures

Primary Outcomes (1)

  • efficacy endpoint

    number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;

    12 weeks

Secondary Outcomes (4)

  • IGA classification change

    12 weeks

  • treatment success rate

    12 weeks

  • PK

    12 weeks

  • PK

    12 weeks

Study Arms (5)

Treat group 1

EXPERIMENTAL

Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride

Drug: Adapalene + Clindamycin Hydrochloride

Treatment group 2

EXPERIMENTAL

Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride

Drug: Adapalene + Clindamycin Hydrochloride

Treatment group 3

EXPERIMENTAL

Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride

Drug: Adapalene + Clindamycin Hydrochloride

Treatment group 4

EXPERIMENTAL

Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride

Drug: Adapalene + Clindamycin Hydrochloride

Placebo group

PLACEBO COMPARATOR

Placebo Group: Blank Gel

Drug: Placebo

Interventions

Adapalene + Clindamycin HydrochlorideDRUG

0.1% Adapalene + 1% Clindamycin Hydrochloride

Treat group 1
PlaceboDRUG
Placebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Dermatology, Chinese Academy of Medical Sciences

Nanjing, Jiangsu, 210042, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

AdapaleneClindamycin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Heng GU, MD

    Institute of Dermatology, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

November 2, 2015

Study Start

March 1, 2015

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

CN(1)