AcnePhase 1/2NCT02593383
Compound Adapalene and Clindamycin Hydrochloride Gel in Treatment of Patients With Acne
A Phase 1/2 study testing Adapalene + Clindamycin Hydrochloride in people with Acne, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne
- What is being tested?
- Adapalene + Clindamycin Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2015to 31 Jul 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Dermatology, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, 210042
About this study
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
evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.
- Conditions
- Acne
- Being tested
- Adapalene + Clindamycin Hydrochloride, Placebo
- Keywords
- safety, efficacy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapalene + Clindamycin HydrochlorideDrug
0.1% Adapalene + 1% Clindamycin Hydrochloride
Adapalene + Clindamycin HydrochlorideDrug
0.1% Adapalene + 2% Clindamycin Hydrochloride
Adapalene + Clindamycin HydrochlorideDrug
0.05% Adapalene + 0.5% Clindamycin Hydrochloride
Adapalene + Clindamycin HydrochlorideDrug
0.05% Adapalene + 1% Clindamycin Hydrochloride
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treat group 1 | Experimental | Group 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride Receives: Drug: Adapalene + Clindamycin Hydrochloride |
| Treatment group 2 | Experimental | Group 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride Receives: Drug: Adapalene + Clindamycin Hydrochloride |
| Treatment group 3 | Experimental | Group 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride Receives: Drug: Adapalene + Clindamycin Hydrochloride |
| Treatment group 4 | Experimental | Group 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride Receives: Drug: Adapalene + Clindamycin Hydrochloride |
| Placebo group | Placebo comparator | Placebo Group: Blank Gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy endpoint
number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;
Measured: 12 weeks
Secondary outcomes (4)
IGA classification change
The improvement of IGA （investigator general Assess）Classification at the treatment end (Day 85±3) in each group
Measured: 12 weeks
treatment success rate
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
Measured: 12 weeks
PK
AUC
Measured: 12 weeks
PK
peak plasma concentration
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start1 Mar 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heng GU, MD, Principal investigator, Institute of Dermatology, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593383
- Sponsor's protocol ID
- zhaoke-2015-02
- Status last verified
- Sep 2019
- First submitted
- 16 Jul 2015
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02593383
- Acronym / sponsor ID
- zhaoke-2015-02
- Conditions
- Acne
- Keywords
- safety, efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
evaluate the safety and efficacy of Compound Adapalene and Clindamycin Hydrochloride Gel in treatment of chinese patients with acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treat group 1 | Experimental | Drug: Adapalene + Clindamycin HydrochlorideGroup 1: 0.1% Adapalene + 1% Clindamycin Hydrochloride |
| Treatment group 2 | Experimental | Drug: Adapalene + Clindamycin HydrochlorideGroup 2: 0.1% Adapalene + 2% Clindamycin Hydrochloride |
| Treatment group 3 | Experimental | Drug: Adapalene + Clindamycin HydrochlorideGroup 3: 0.05% Adapalene + 0.5% Clindamycin Hydrochloride |
| Treatment group 4 | Experimental | Drug: Adapalene + Clindamycin HydrochlorideGroup 4: 0.05% Adapalene + 1% Clindamycin Hydrochloride |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo Group: Blank Gel |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapalene + Clindamycin Hydrochloride0.1% Adapalene + 1% Clindamycin Hydrochloride | Drug | Treat group 1 |
| Adapalene + Clindamycin Hydrochloride0.1% Adapalene + 2% Clindamycin Hydrochloride | Drug | Treatment group 2 |
| Adapalene + Clindamycin Hydrochloride0.05% Adapalene + 0.5% Clindamycin Hydrochloride | Drug | Treatment group 3 |
| Adapalene + Clindamycin Hydrochloride0.05% Adapalene + 1% Clindamycin Hydrochloride | Drug | Treatment group 4 |
| Placebo | Drug | Placebo group |
Primary outcome
efficacy endpoint
Time frame: 12 weeks
number of patients with deceased acne lesions at the treatment end (Day 85±3) in each group;
4 secondary outcomes
IGA classification change
Time frame: 12 weeks
treatment success rate
Time frame: 12 weeks
PK
Time frame: 12 weeks
PK
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
Related trials for Acne
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heng GU, MD principal investigator
Institute of Dermatology, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adapalene + Clindamycin Hydrochloride in people with Acne, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy endpoint (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.