A Phase 4 interventional study of Herbal depigmenting agent (Epionce) and Hydroquinone in Melasma and Hyperpigmentation, sponsored by Sadick Research Group. Completed at 1 site in United States. Open to female participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-18.
Sponsored by Sadick Research Group · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and tolerability of an herbal de-pigmenting regimen applied to one side of the face compared with hydroquinone applied to the other side of the face in treating mottled hyperpigmentation and melasma.
This clinical study is being conducted in order to evaluate the effectiveness and tolerability of a de-pigmenting regimen when used by subjects with mild to severe mottled hyperpigmentation and melasma. Efficacy will be assessed using visual grading, device measurements and digital photography. Tolerance and safety will be evaluated by grading for objective and subjective signs of irritation, and the incidence and severity of adverse events. Efficacy and tolerance of this product are compared to that of Hydroquinone, which is applied to one side of the subject's face while the herbal de-pigmenting regimen is applied to the other side of the face.
The two product pigmentation reducing herbal regimen is based on the novel concept of inhibiting all 14 major and the 3 branch steps in the melanin cascade.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Sadick Research Group is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4% hydroquinone applied to one side of the face.
Drug: Hydroquinone
Herbal depigmenting agent applied on the other side of the face.
Other: Herbal depigmenting agent (Epionce)
A two product herbal pigmentation reducing regimen is applied twice a day to either the left or right side of the face for a duration of 4 months.
Also known as: Epionce
Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.
Melanin Index
The melanin index of the skin will be measured at baseline and at each follow-up visit with a non-invasive device. At the end of the study, the change of the Melanin index over a period of 6 months will be calculated.
Time frame: 6 months
Irritation
Both objective irritation (erythema, edema, peeling, scaling/dryness) and subjective irritation (burning/stinging, itching, dry/tight feeling) will be measured at each visit via visual grading assessments and subject questionnaires.
Time frame: Baseline, 1 month, 2 month, 4 month, 6 months
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Sadick Research Group