HyperpigmentationPhase 2NCT05511948
Randomized and Open Label Study for Safety and Efficacy of DBI-102 vs. Vehicle vs. Hydroquinone on Skin Pigmentation and Lentigos
A Phase 2 study testing DBI-102 and Hydroquinone Cream in people with Hyperpigmentation, run by DermBiont, Inc. at 1 site in El Salvador.
Trial summary
This is a randomized, observer-blinded, vehicle-controlled multi-dose trial that examines the effect of twice daily application of 0.8% DBI-102 Gel, 4% Hydroquinone cream, and Vehicle Gel for 12 weeks in adults with Fitzpatrick Skin Types IV-V and a colorimeter L* measurement between 57.8 and 46.1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation
- What is being tested?
- DBI-102 and Hydroquinone Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEl Salvador
- Study dates
- 18 Aug 2022to 7 Mar 2023
- Phase
- Phase 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female at least 18 years of age.
- Must be Fitzpatrick Skin Type IV-V and have an L* measurement between 57.8 and 46.1, using the Chromometer CM-700.
- Ability to understand, agree to, and sign the study informed consent form (ICF).
- Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted.
- Agree not to change their sun exposure at work, home, or leisure.
- Technical ability and willingness to apply test articles.
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- Willing to allow digital photos of treatment and comparison areas to be taken and stored.
- Additional Inclusion Criterion for the solar lentigo Sub-Cohort:
- At least 4 solar lentigos at least 4 mm in diameter present on each dorsal hand.
Who cannot join
- Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study.
- Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to, melasma or vitiligo affecting the treatment and comparison sites.
- Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).
- Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.
- Current or past use of monobenzyl ether or hydroquinone (Benoquin) to depigment the skin.
- Past or recent use of any skin bleaching treatment within 6 months of Screening.
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- A chemical peel within 3 months of Screening.
- Laser or light-based treatment of the treatment areas within 3 months of Screening.
- Use of any photosensitizing medications within the past 6 months of Screening, including psoralens, sulfonamide drugs, tetracycline antibiotics, thiazide diuretics, phenothiazines, coal tar and derivatives, and tricyclic antidepressants.
- Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the subject to an unacceptable risk by study participation.
- Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see Exclusion criteria 5 and 6).
- Unwilling to discontinue applying any prescription or over the counter (OTC) topical product creams and ointments, other than makeup and moisturizers, on treatment area(s) at Baseline through their last day of study.
- Treatment of any type of cancer within 6 months of Screening with the exception of superficial skin cancers such as basal cell or squamous cell carcinoma.
- Known allergy to any of the test article(s) or any components in the test article(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
- History of active atopic dermatitis, as diagnosed by a physician, requiring treatment within the past 2 years.
- Unable to meet the study attendance requirements.
- Any history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- Participation in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.
- Additional Exclusion Criterion for the Sub-Cohort
- Any previous treatment for solar lentigos on the dorsal hands.
Trial locations and contacts
1 site in 1 country.
El Salvador1 site
Zepeda Dermatologia
Santa Tecla, La Libertad Department, CP1501
About this study
Official title: A Randomized, Observer-Blinded, Vehicle-Controlled Study on the Safety and Efficacy of Twice Daily Application of Ruboxistaurin (DBI-102) Gel Vs.Vehicle Gel Vs. Hydroquinone Cream on Sun-Exposed and Sun-Protected Skin of Adults
This is a randomized, observer-blinded, vehicle-controlled multi-dose trial that examines the effect of twice daily application of 0.8% DBI-102 Gel, 4% Hydroquinone cream, and Vehicle Gel for 12 weeks in adults with Fitzpatrick Skin Types IV-V and a colorimeter L* measurement between 57.8 and 46.1.
- Conditions
- Hyperpigmentation
- Being tested
- DBI-102, Vehicle gel, Hydroquinone Cream
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBI-102Drug
Topical application on dorsal hand and upper volar arm
Vehicle gelDrug
Inactive comparator
Hydroquinone CreamDrug
4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| DBI-102 | Experimental | Topical DBI-102 Gel, 0.8% twice daily for 12 weeks for the randomized cohort Receives: Drug: DBI-102 |
| Vehicle gel | Placebo comparator | Inactive comparator Receives: Drug: Vehicle gel |
| Hydroquinone cream | Active comparator | 4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks Receives: Drug: Hydroquinone Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in pigmentation based on melanin index
Change in L* and ITA colorimetry measurements
Measured: 12 weeks after first dose
Decrease in pigmentation based on digital imaging
Change as measured with Canfield RBX software analysis
Measured: 12 weeks after first dose
Secondary outcomes (2)
Percent Change in Investigator Dynamic Grading Assessment (IDGA)
Percent pigmentation differences between treated and contralateral Percent Change in Investigator Dynamic Grading Assessment (IDGA)
Measured: At weeks 2,4,6,8,10, and 12
Proportion of subjects with Improved Investigator Dynamic Grading Scale (IDGA)
Proportion of subjects with less pigmentation at treated sites vs contralateral untreated sites
Measured: At weeks 2,4,6,8,10, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start18 Aug 2022
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized 3-arm tranche of main cohorts, to be followed by open-label Solar Lentigo sub-cohort
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermBiont, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Zepeda, MD, Principal investigator, Zepeda Dermatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511948
- Sponsor's protocol ID
- CT-212
- Status last verified
- Oct 2023
- First submitted
- 20 Aug 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blinded, Vehicle-Controlled Study on the Safety and Efficacy of Twice Daily Application of Ruboxistaurin (DBI-102) Gel Vs.Vehicle Gel Vs. Hydroquinone Cream on Sun-Exposed and Sun-Protected Skin of Adults
- ClinicalTrials.gov ID
- NCT05511948
- Acronym / sponsor ID
- CT-212
- Conditions
- Hyperpigmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- DermBiont, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 23 Aug 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.
This is a randomized, observer-blinded, vehicle-controlled multi-dose trial that examines the effect of twice daily application of 0.8% DBI-102 Gel, 4% Hydroquinone cream, and Vehicle Gel for 12 weeks in adults with Fitzpatrick Skin Types IV-V and a colorimeter L* measurement between 57.8 and 46.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized 3-arm tranche of main cohorts, to be followed by open-label Solar Lentigo sub-cohort
| Arm | Type | Receives |
|---|---|---|
| DBI-102 | Experimental | Drug: DBI-102Topical DBI-102 Gel, 0.8% twice daily for 12 weeks for the randomized cohort |
| Vehicle gel | Placebo comparator | Drug: Vehicle gelInactive comparator |
| Hydroquinone cream | Active comparator | Drug: Hydroquinone Cream4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female at least 18 years of age.
- Must be Fitzpatrick Skin Type IV-V and have an L* measurement between 57.8 and 46.1, using the Chromometer CM-700.
- Ability to understand, agree to, and sign the study informed consent form (ICF).
- Agree to discontinue all agents used to treat hyperpigmentation, aging or exfoliate the skin during the course of the study. Makeup and moisturizers are permitted.
- Agree not to change their sun exposure at work, home, or leisure.
Key exclusion criteria (20 listed)
- Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study.
- Conditions at baseline that would interfere with evaluation of UV-tanned skin, especially other pigmentary disorders including, but not limited to, melasma or vitiligo affecting the treatment and comparison sites.
- Presence of known concomitant diseases associated with the development of hyperpigmentation (e.g., thyroid, liver, adrenal).
- Current tanning booth exposure or any kind of phototherapy within 3 months of Screening.
- Current or past use of monobenzyl ether or hydroquinone (Benoquin) to depigment the skin.
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 |
|---|---|---|
| DBI-102Topical application on dorsal hand and upper volar arm | Drug | DBI-102 |
| Vehicle gelInactive comparator | Drug | Vehicle gel |
| Hydroquinone Cream4% Hydroquinone cream, Acella (approved), twice daily for 12 weeks | Drug | Hydroquinone cream |
Primary outcome
Decrease in pigmentation based on melanin index
Time frame: 12 weeks after first dose
Change in L* and ITA colorimetry measurements
Decrease in pigmentation based on digital imaging
Time frame: 12 weeks after first dose
Change as measured with Canfield RBX software analysis
2 secondary outcomes
Percent Change in Investigator Dynamic Grading Assessment (IDGA)
Time frame: At weeks 2,4,6,8,10, and 12
Proportion of subjects with Improved Investigator Dynamic Grading Scale (IDGA)
Time frame: At weeks 2,4,6,8,10, and 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 25 Oct 2023.
- 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.
David Zepeda, MD principal investigator
Zepeda Dermatologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DBI-102 and Hydroquinone Cream in people with Hyperpigmentation, run by DermBiont, Inc. at 1 site in El Salvador.
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 9 inclusion and 20 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 25 Oct 2023. 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 El Salvador. 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 phase mean?
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?
Decrease in pigmentation based on melanin index (time frame: 12 weeks after first dose). 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?
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 25 Oct 2023.