MelasmaNCT04137263
Study Evaluating the Efficacy of DOSE Formulations in Treating Melasma and Cutaneous Signs of Aging
A study testing DOSE formulation in people with Melasma, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
The primary objective is to evaluate the efficacy, of D.O.S.E formulations in the treatment of melasma and cutaneous signs of aging. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melasma
- What is being tested?
- DOSE formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Dec 2020
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Females age 18-65, Fitzpatrick skin types I-VI 2. Mild to moderate melasma 3. Half of subjects with hypervascular melasma identified by Visia complexion analysis 4. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
- 5. Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
- 6. Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
- 7. Women of childbearing potential willing to use an acceptable form of birth control during trial period.
- Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
- Intrauterine coil
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- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
- Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
- 8. Female patients will be either of non-childbearing potential defined as: Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12 months prior), or has had a bilateral tubal ligation at least 6 months prior to study enrollment.
Who cannot join
- 1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
- 2. Known hypersensitivity or allergy to the components of the study medication. 3. Concurrent enrollment in any study involving the use of investigational devices or drugs.
- 4. Current smoker or history of smoking in the last five years. 5. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- 6. Presence of an active systemic or local skin disease that may affect treatment area.
- 7. History of the following cosmetic treatments to the area(s) to be treated:
- Energy based device or laser procedure to the area within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
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- Medium to deep chemical peels (e.g. TCA, Phenol) for 6 months or light chemical peels (e.g. Glycolic Acid >20%) within the past 3 months; 8. History of using the following cosmetic, OTC or prescription medications:
- Topical glycolic acid (5% or greater) in the past 4 weeks. b. Topical or oral tranexamic acid within in the past 4 weeks (e.g. Lytera 2.0); c. Topical Retinoids (e.g. Rx tretinoin or OTC retinol) within the past four weeks; d. Topical hydroquinone within the past 4 weeks; e. Topical salicylic acid within the past 4 weeks; f. Topical or oral corticosteroids within the past 4 weeks; g. Other topical products intended to treat melasma within the past 4 weeks; 9. Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- 10. Any planned surgical intervention to the treatment area for the duration of the trial 11. Any visible surface alteration to the treatment area that may interfere with evaluation, at investigator discretion 12. Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion 13. Inability to comply with all study protocols and regulations 14. Current taking an immunosuppressant or applying a topical corticosteroid to the affected area
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: A Prospective, Study Evaluating the Efficacy of DOSE Formulations in Treatment of Melasma and Cutaneous Signs of Aging
The primary objective is to evaluate the efficacy, of D.O.S.E formulations in the treatment of melasma and cutaneous signs of aging.
Read the detailed description
Melasma is a hyperpigmentation disorder that presents as irregularly shaped macules on the face of women. The etiology is unknown however there is strong evidence that genetics, hormones, sun exposure can trigger and worsen the disease. Increased dermal vascularity and expression of angiogenic factors also seem to play a role. Melasma is a chronic and relapsing condition, that is difficult to treat, and can have a negative impact on quality of life.
Numerous treatments exist for melasma including topical lightening agents, chemical peels, and a variety of laser and light based options. Long-term management is difficult as topical agents can often cause irritation, burning, peeling and inflammatory hyperpigmentation. Light based therapies can also lead to relapse or worsening of the disease.
Melasma, in combination with photodamage from cumulative sun exposure and aging, can lead to a complex picture when making a skin care plan for a cosmetic patient. The custom D.O.S.E professional service can be utilized to make a personalized serum to improve skin discoloration and the visible signs of aging. The purpose of this study is to evaluate the efficacy of D.O.S.E formulations in the treatment of melasma and visible signs of aging.
- Conditions
- Melasma
- Being tested
- DOSE formulation
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOSE formulationOther
over-the-counter topical
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will receive dose formulation for treatment of melasma Receives: Other: DOSE formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Melasma
change in Investigator MoPASI score
Measured: Baseline to Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- L'Oreal
- Responsible party
- Sponsor
- Investigators
- Monica Boen, M.D., Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137263
- Sponsor's protocol ID
- DOSE-2019-01
- Status last verified
- Dec 2020
- First submitted
- 22 Oct 2019
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Study Evaluating the Efficacy of DOSE Formulations in Treatment of Melasma and Cutaneous Signs of Aging
- ClinicalTrials.gov ID
- NCT04137263
- Acronym / sponsor ID
- DOSE-2019-01
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- L'Oreal
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Oct 2019 (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.
The primary objective is to evaluate the efficacy, of D.O.S.E formulations in the treatment of melasma and cutaneous signs of aging.
Detailed description
Melasma is a hyperpigmentation disorder that presents as irregularly shaped macules on the face of women. The etiology is unknown however there is strong evidence that genetics, hormones, sun exposure can trigger and worsen the disease. Increased dermal vascularity and expression of angiogenic factors also seem to play a role. Melasma is a chronic and relapsing condition, that is difficult to treat, and can have a negative impact on quality of life.
Numerous treatments exist for melasma including topical lightening agents, chemical peels, and a variety of laser and light based options. Long-term management is difficult as topical agents can often cause irritation, burning, peeling and inflammatory hyperpigmentation. Light based therapies can also lead to relapse or worsening of the disease.
Melasma, in combination with photodamage from cumulative sun exposure and aging, can lead to a complex picture when making a skin care plan for a cosmetic patient. The custom D.O.S.E professional service can be utilized to make a personalized serum to improve skin discoloration and the visible signs of aging. The purpose of this study is to evaluate the efficacy of D.O.S.E formulations in the treatment of melasma and visible signs of aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: DOSE formulationSubjects will receive dose formulation for treatment of melasma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Females age 18-65, Fitzpatrick skin types I-VI 2. Mild to moderate melasma 3. Half of subjects with hypervascular melasma identified by Visia complexion analysis 4. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
- 5. Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
- 6. Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
- 7. Women of childbearing potential willing to use an acceptable form of birth control during trial period.
- 8. Female patients will be either of non-childbearing potential defined as: Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12 months prior), or has had a bilateral tubal ligation at least 6 months prior to study enrollment.
Key exclusion criteria (9 listed)
- 1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
- 2. Known hypersensitivity or allergy to the components of the study medication. 3. Concurrent enrollment in any study involving the use of investigational devices or drugs.
- 4. Current smoker or history of smoking in the last five years. 5. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- 6. Presence of an active systemic or local skin disease that may affect treatment area.
- 10. Any planned surgical intervention to the treatment area for the duration of the trial 11. Any visible surface alteration to the treatment area that may interfere with evaluation, at investigator discretion 12. Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion 13. Inability to comply with all study protocols and regulations 14. Current taking an immunosuppressant or applying a topical corticosteroid to the affected area
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 |
|---|---|---|
| DOSE formulationover-the-counter topical | Other | Treatment |
Primary outcome
Improvement of Melasma
Time frame: Baseline to Day 120
change in Investigator MoPASI score
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 20 Mar 2024.
- 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.
Monica Boen, M.D. principal investigator
Cosmetic Laser Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOSE formulation in people with Melasma, run by Goldman, Butterwick, Fitzpatrick and Groff 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 10 inclusion and 9 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 20 Mar 2024. 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.
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?
Improvement of Melasma (time frame: Baseline to Day 120). 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 20 Mar 2024.