Acne VulgarisPhase 3NCT03615768
A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris
A Phase 3 study testing Adapalene-Clindamycin Combination Gel, Adapalene Gel and Clindamycin Gel in people with Acne Vulgaris, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Adapalene-Clindamycin Combination Gel, Adapalene Gel and Clindamycin Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,617 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2018to 7 Apr 2020
- Phase
- Phase 3
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, 210042
About this study
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
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.
- Conditions
- Acne Vulgaris
- Being tested
- Adapalene-Clindamycin Combination Gel, Adapalene Gel, Clindamycin Gel
- 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 Combination GelCombination product
5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks
Adapalene GelDrug
Also called Differin
Differin 0.1% Gel, applied nightly for 12 weeks
Clindamycin GelDrug
Also called Clindamycin
Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adapalene-Clindamycin Combination Gel | Experimental | Not described Receives: Combination Product: Adapalene-Clindamycin Combination Gel |
| Adapalene Gel | Active comparator | Not described Receives: Drug: Adapalene Gel |
| Clindamycin Gel | Active comparator | Not described Receives: Drug: Clindamycin Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Total Lesion Counts
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Measured: Week 12
Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline
Measured: Week 12
Secondary outcomes (7)
Percentage change from baseline in inflammatory lesion counts
Percent change from baseline in inflammatory lesions count in each treatment group at Week 12.
Measured: Week 12
Percentage change from baseline in non-inflammatory lesion counts
Percent change from baseline in non-inflammatory lesions count in each treatment group at Week 12.
Measured: Week 12
Change from baseline in inflammatory lesion counts
Absolute change from baseline in inflammatory lesion counts in each treatment group at Week 12.
Measured: Week 12
Change from baseline in non-inflammatory lesion counts
Absolute change from baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Measured: Week 12
Change from baseline in total lesion counts
Absolute change from baseline in total lesions counts in each treatment group at Week 12.
Measured: Week 12
Change from baseline in Investigator's Global Assessment (IGA)
Absolute change from baseline in Investigator's Global Assessment (IGA) in each treatment group at Week 12.
Measured: Week 12
Treatment success rate
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start14 Aug 2018
- Primary completion13 Feb 2020
- Study completion7 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Responsible party
- Sponsor
- Investigators
- Heng Gu, MD, Principal investigator, Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615768
- Sponsor's protocol ID
- ZK-ACG-201712
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luan C, Yang WL, Yin JW, Deng LH, Chen B, Liu HW, Zhang SM, Han J, Liu ZJ, Dai XR, Yin QJ, Yu XH, Chen K, Gu H, Li BXY. Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial. Dermatol Ther (Heidelb). 2024 Nov;14(11):3097-3112. doi: 10.1007/s13555-024-01286-x. Epub 2024 Nov 1.
PubMed 39487326
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03615768
- Acronym / sponsor ID
- ZK-ACG-201712
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,617 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adapalene-Clindamycin Combination Gel | Experimental | Combination Product: Adapalene-Clindamycin Combination Gel |
| Adapalene Gel | Active comparator | Drug: Adapalene Gel |
| Clindamycin Gel | Active comparator | Drug: Clindamycin Gel |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
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 Combination Gel5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks | Combination product | Adapalene-Clindamycin Combination Gel |
| Adapalene GelAlso: DifferinDifferin 0.1% Gel, applied nightly for 12 weeks | Drug | Adapalene Gel |
| Clindamycin GelAlso: ClindamycinClindamycin Phosphate 1% Gel applied twice daily for 12 weeks | Drug | Clindamycin Gel |
Primary outcome
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.
Proportion of patients who has at least a two-point reduction in Investigator Global Assessment (IGA) compared to baseline
Time frame: Week 12
7 secondary outcomes
Percentage change from baseline in inflammatory lesion counts
Time frame: Week 12
Percentage change from baseline in non-inflammatory lesion counts
Time frame: Week 12
Change from baseline in inflammatory lesion counts
Time frame: Week 12
Change from baseline in non-inflammatory lesion counts
Time frame: Week 12
Change from baseline in total lesion counts
Time frame: Week 12
Change from baseline in Investigator's Global Assessment (IGA)
Time frame: Week 12
Treatment success rate
Time frame: Week 12
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 28 Apr 2020.
- Derived from this study: PubMed 39487326Luan C, Yang WL, Yin JW, Deng LH, Chen B, Liu HW, Zhang SM, Han J, Liu ZJ, Dai XR, Yin QJ, Yu XH, Chen K, Gu H, Li BXY. Efficacy and Safety of a Fixed-Dose Combination Gel with Adapalene 0.1% and Clindamycin 1% for the Treatment of Acne Vulgaris (CACTUS): A Randomized, Controlled, Assessor-Blind, Phase III Clinical Trial. Dermatol Ther (Heidelb). 2024 Nov;14(11):3097-3112. doi: 10.1007/s13555-024-01286-x. Epub 2024 Nov 1.
- Individual participant dataSharing planned: No
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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 and Hospital for Skin Diseases, 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 3 study testing Adapalene-Clindamycin Combination Gel, Adapalene Gel and Clindamycin Gel in people with Acne Vulgaris, 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 28 Apr 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage Change From Baseline in Total Lesion Counts (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615768, which also lists 1 linked publication.
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 28 Apr 2020.