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A Prospective, Study Evaluating the Efficacy of DOSE Formulations in Treatment of Melasma and Cutaneous Signs of Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137263
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
SkinCeuticals
Information provided by (Responsible Party):
Goldman, Butterwick, Fitzpatrick and Groff

Brief 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.

Condition or disease Intervention/treatment Phase
Melasma Other: DOSE formulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Study Evaluating the Efficacy of DOSE Formulations in Treatment of Melasma and Cutaneous Signs of Aging
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: Treatment
Subjects will receive dose formulation for treatment of melasma
Other: DOSE formulation
over-the-counter topical




Primary Outcome Measures :
  1. Improvement of Melasma [ Time Frame: Baseline to Day 120 ]
    change in Investigator MoPASI score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

    1. Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
    2. Intrauterine coil
    3. Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
    4. Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
    5. 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:

    1. Energy based device or laser procedure to the area within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
    2. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137263


Contacts
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Contact: Daniel Leeper 8586571004 dleeper@clderm.com
Contact: Leslie Aguilar 8586571004 laguilar@clderm.com

Locations
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United States, California
Cosmetic Laser Dermatology Recruiting
San Diego, California, United States, 92121
Contact: Isabella C Guiha    858-657-1004    IGuiha@CLDerm.com   
Sponsors and Collaborators
Goldman, Butterwick, Fitzpatrick and Groff
SkinCeuticals
Investigators
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Principal Investigator: Monica Boen, M.D. Cosmetic Laser Dermatology
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Responsible Party: Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier: NCT04137263    
Other Study ID Numbers: DOSE-2019-01
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases