- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137263
Study Evaluating the Efficacy of DOSE Formulations in Treating Melasma and Cutaneous Signs of Aging
A Prospective, Study Evaluating the Efficacy of DOSE Formulations in Treatment of Melasma and Cutaneous Signs of Aging
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- Cosmetic Laser Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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)
- 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:
a. 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Subjects will receive dose formulation for treatment of melasma
|
over-the-counter topical
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Melasma
Time Frame: Baseline to Day 120
|
change in Investigator MoPASI score
|
Baseline to Day 120
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Monica Boen, M.D., Cosmetic Laser Dermatology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOSE-2019-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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