AcneEarly Phase 1NCT05582434
Experience With Topical Acne Treatment
A Early Phase 1 study testing clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel, adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel and Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel in people with Acne, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acne
- What is being tested?
- clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel, adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel and Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to Nov 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥18 years of age
- Patients with a current diagnosis of acne
- Patients who live in the US,
- Patients have sufficient command of the English language
Who cannot join
- Patients less than the age of 18
- Patients without a current diagnosis of acne
- Patients who do not live in the US
- Patients without a sufficient command of the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications
Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2
- Conditions
- Acne
- Being tested
- clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel, adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel, Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% 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.
clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gelDrug
Also called Cabtreo®
Single topical treatment to be applied daily to area affected once daily.
adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gelDrug
Also called Epiduo® Forte and Clindamycin
Two topical treatments to be applied to area affected once daily.
Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gelDrug
Also called Differin®, Epsolay, Clindamycin
Three topical treatments to be applied to area affected once daily.
| Study group | Role | What they receive |
|---|---|---|
| One single fixed-combination product | Experimental | Participants instructed to apply clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel once daily Receives: Drug: clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel |
| Two products | Experimental | Participants instructed to apply 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel once daily Receives: Drug: adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel |
| Three products | Experimental | Participants instructed to apply BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel once daily Receives: Drug: Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached
Measured: End of study visit - day 56
Medication Adherence
Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened
Measured: End of study visit - day 56
Secondary outcomes (2)
Gender specific adherence (female subjects)
Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome
Measured: End of study visit - day 56
Gender specific adherence (male subjects)
Difference in medication adherence between the male and female subjects. The outcome will compare the two categories in the primary outcome
Measured: End of study visit - day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start15 Feb 2024
- Primary completion19 Jun 2025
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582434
- Sponsor's protocol ID
- IRB00089304
- Status last verified
- Dec 2025
- First submitted
- 10 Oct 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lott R, Taylor SL, O'Neill JL, Krowchuk DP, Feldman SR. Medication adherence among acne patients: a review. J Cosmet Dermatol. 2010 Jun;9(2):160-6. doi: 10.1111/j.1473-2165.2010.00490.x.
PubMed 20618564Moradi Tuchayi S, Alexander TM, Nadkarni A, Feldman SR. Interventions to increase adherence to acne treatment. Patient Prefer Adherence. 2016 Oct 11;10:2091-2096. doi: 10.2147/PPA.S117437. eCollection 2016.
PubMed 27784999Tan X, Al-Dabagh A, Davis SA, Lin HC, Balkrishnan R, Chang J, Feldman SR. Medication adherence, healthcare costs and utilization associated with acne drugs in Medicaid enrollees with acne vulgaris. Am J Clin Dermatol. 2013 Jun;14(3):243-51. doi: 10.1007/s40257-013-0016-x.
PubMed 23572294
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Medication Adherence to Topical Acne Medications: a Single-center, Prospective Study Evaluating the Adherence and Patient Satisfaction to Single and Multiple Topical Acne Medications
- ClinicalTrials.gov ID
- NCT05582434
- Acronym / sponsor ID
- IRB00089304
- Conditions
- Acne
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Oct 2022 (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.
Acne is a chronic condition that typically requires the use of multiple medications.1 Medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 Nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. Primary nonadherence refers to problems acquiring and starting treatment. Challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 Secondary nonadherence refers to when the patient does not use the medication as prescribed. Hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One single fixed-combination product | Experimental | Drug: clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gelParticipants instructed to apply clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel once daily |
| Two products | Experimental | Drug: adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gelParticipants instructed to apply 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel once daily |
| Three products | Experimental | Drug: Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gelParticipants instructed to apply BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel once daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ≥18 years of age
- Patients with a current diagnosis of acne
- Patients who live in the US,
- Patients have sufficient command of the English language
Key exclusion criteria (4 listed)
- Patients less than the age of 18
- Patients without a current diagnosis of acne
- Patients who do not live in the US
- Patients without a sufficient command of the English language
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 |
|---|---|---|
| clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gelAlso: Cabtreo®Single topical treatment to be applied daily to area affected once daily. | Drug | One single fixed-combination product |
| adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gelAlso: Epiduo® Forte and ClindamycinTwo topical treatments to be applied to area affected once daily. | Drug | Two products |
| Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gelAlso: Differin®, Epsolay, ClindamycinThree topical treatments to be applied to area affected once daily. | Drug | Three products |
Primary outcome
Medication Adherence
Time frame: End of study visit - day 56
Medication adherence measured by recording the weight of medication (in milligrams) in the bottle with electronic monitor attached
Medication Adherence
Time frame: End of study visit - day 56
Medication adherence measured by the data from the electronic monitors by frequency of use recorded by number of times opened
2 secondary outcomes
Gender specific adherence (female subjects)
Time frame: End of study visit - day 56
Gender specific adherence (male subjects)
Time frame: End of study visit - day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 20618564Lott R, Taylor SL, O'Neill JL, Krowchuk DP, Feldman SR. Medication adherence among acne patients: a review. J Cosmet Dermatol. 2010 Jun;9(2):160-6. doi: 10.1111/j.1473-2165.2010.00490.x.
- Background: PubMed 27784999Moradi Tuchayi S, Alexander TM, Nadkarni A, Feldman SR. Interventions to increase adherence to acne treatment. Patient Prefer Adherence. 2016 Oct 11;10:2091-2096. doi: 10.2147/PPA.S117437. eCollection 2016.
- Background: PubMed 23572294Tan X, Al-Dabagh A, Davis SA, Lin HC, Balkrishnan R, Chang J, Feldman SR. Medication adherence, healthcare costs and utilization associated with acne drugs in Medicaid enrollees with acne vulgaris. Am J Clin Dermatol. 2013 Jun;14(3):243-51. doi: 10.1007/s40257-013-0016-x.
- Individual participant dataSharing planned: No
Related trials for Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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
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.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel, adapalene 0.3%/BPO 2.5% gel and compounded clindamycin phosphate 1.2% gel and Compounded BPO 2.5% gel, adapalene 0.1% gel, and compounded clindamycin phosphate 1.2% gel in people with Acne, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Medication Adherence (time frame: End of study visit - day 56). 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 NCT05582434, which also lists 3 linked publications.
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 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.